Clinical trial NCT01553591: Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Lead sponsor: Furiex Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

1. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
2. Participant has had a colonoscopy performed:

   * Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
   * Since the onset (if applicable) of any of the following alarm features for participants of any age:

     * Participant has documented weight loss within the past 6 months
     * Participant has nocturnal symptoms
     * Participant has a familial history of first-degree relatives with colon cancer or
     * Participant has blood mixed with their stool (excluding blood from hemorrhoids).
3. Female participants must be:

   * Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
   * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
   * Abstinent, or
   * If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

1. Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
2. Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
3. Participant has a history of diverticulitis within 3 months prior to Prescreening.
4. Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
5. Participant has any of the following surgical history:

   * Cholecystectomy with any history of post cholecystectomy biliary tract pain
   * Any abdominal surgery within the 3 months prior to Prescreening
   * Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
timeFrame: Up to 26 Weeks
measure: Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
timeFrame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
measure: Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
timeFrame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
measure: Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
timeFrame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
measure: Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
timeFrame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])
measure: Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
timeFrame: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
measure: Change From Baseline in Daily Abdominal Discomfort Scores
timeFrame: Baseline, Weeks 4, 12 and 26
measure: Change From Baseline in Daily Abdominal Bloating Scores
timeFrame: Baseline, Weeks 4, 12 and 26
measure: Number of Bowel Movements Per Day
timeFrame: Weeks 4, 12 and 26
measure: Number of Bowel Incontinence Episodes
timeFrame: Weeks 4, 12 and 26
measure: Number of Bowel Incontinence Free Days
timeFrame: Weeks 4, 12 and 26
measure: Number of Urgency Episodes Per Day
timeFrame: Weeks 4, 12 and 26
measure: IBS-QoL Total Scores
timeFrame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)
measure: Change From Baseline in IBS-QoL Total Scores
timeFrame: Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT
Other outcomes:
Locations:
city: Athens
country: United States
facility: Furiex Research Site
state: Alabama
city: Birmingham
country: United States
facility: Furiex Research Site
state: Alabama
city: Foley
country: United States
facility: Furiex Research Site
state: Alabama
city: Huntsville
country: United States
facility: Furiex Research Site
state: Alabama
city: Ozark
country: United States
facility: Furiex Research Site
state: Alabama
city: Chandler
country: United States
facility: Furiex Research Site
state: Arizona
city: Glendale
country: United States
facility: Furiex Research Site
state: Arizona
city: Mesa
country: United States
facility: Furiex Research Site
state: Arizona
city: Phoenix
country: United States
facility: Furiex Research Site
state: Arizona
city: Tucson
country: United States
facility: Furiex Research Site
state: Arizona
city: Little Rock
country: United States
facility: Furiex Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Furiex Research Site
state: Arkansas
city: North Little Rock
country: United States
facility: Furiex Research Site
state: Arkansas
city: Azusa
country: United States
facility: Furiex Research Site
state: California
city: Bell Gardens
country: United States
facility: Furiex Research Site
state: California
city: Beverly Hills
country: United States
facility: Furiex Research Site
state: California
city: Carson
country: United States
facility: Furiex Research Site
state: California
city: Chula Vista
country: United States
facility: Furiex Research Site
state: California
city: Corona
country: United States
facility: Furiex Research Site
state: California
city: El Cajon
country: United States
facility: Furiex Research Site
state: California
city: Encino
country: United States
facility: Furiex Research Site
state: California
city: Garden Grove
country: United States
facility: Furiex Research Site
state: California
city: Lomita
country: United States
facility: Furiex Research Site
state: California
city: Los Angeles
country: United States
facility: Furiex Research Site
state: California
city: Monterey Park
country: United States
facility: Furiex Research Site
state: California
city: Murrieta
country: United States
facility: Furiex Research Site
state: California
city: Newport Beach
country: United States
facility: Furiex Research Site
state: California
city: North Hollywood
country: United States
facility: Furiex Research Site
state: California
city: Oakland
country: United States
facility: Furiex Research Site
state: California
city: Oxnard
country: United States
facility: Furiex Research Site
state: California
city: Pismo Beach
country: United States
facility: Furiex Research Site
state: California
city: Poway
country: United States
facility: Furiex Research Site
state: California
city: Riverside
country: United States
facility: Furiex Research Site
state: California
city: Roseville
country: United States
facility: Furiex Research Site
state: California
city: Sacramento
country: United States
facility: Furiex Research Site
state: California
city: San Diego
country: United States
facility: Furiex Research Site
state: California
city: San Diego
country: United States
facility: Furiex Research Site
state: California
city: Santa Monica
country: United States
facility: Furiex Research Site
state: California
city: Thousand Oaks
country: United States
facility: Furiex Research Site
state: California
city: Colorado Springs
country: United States
facility: Furiex Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Furiex Research Site
state: Colorado
city: Lafayette
country: United States
facility: Furiex Research Site
state: Colorado
city: Lakewood
country: United States
facility: Furiex Research Site
state: Colorado
city: Longmont
country: United States
facility: Furiex Research Site
state: Colorado
city: Norwalk
country: United States
facility: Furiex Research Site
state: Connecticut
city: Ridgefield
country: United States
facility: Furiex Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Furiex Research Site
state: Florida
city: Brandon
country: United States
facility: Furiex Research Site
state: Florida
city: Clearwater
country: United States
facility: Furiex Research Site
state: Florida
city: Cooper City
country: United States
facility: Furiex Research Site
state: Florida
city: Coral Springs
country: United States
facility: Furiex Research Site
state: Florida
city: Crystal River
country: United States
facility: Furiex Research Site
state: Florida
city: Doral
country: United States
facility: Furiex Research Site
state: Florida
city: Eustis
country: United States
facility: Furiex Research Site
state: Florida
city: Hialeah
country: United States
facility: Furix Research Site
state: Florida
city: Hialeah
country: United States
facility: Furiex Research Site
state: Florida
city: Inverness
country: United States
facility: Furiex Research Site
state: Florida
city: Jacksonville
country: United States
facility: Furiex Research Site
state: Florida
city: Kissimmee
country: United States
facility: Furiex Research Site
state: Florida
city: Maitland
country: United States
facility: Furiex Research Site
state: Florida
city: Melbourne
country: United States
facility: Furiex Research Site
state: Florida
city: Miami Springs
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Miramar
country: United States
facility: Furiex Research Site
state: Florida
city: Naples
country: United States
facility: Furiex Research Site
state: Florida
city: New Port Richey
country: United States
facility: Furiex Research Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Furiex Research Site
state: Florida
city: Orlando
country: United States
facility: Furiex Research Site
state: Florida
city: Orlando
country: United States
facility: Furiex Research Site
state: Florida
city: Orlando
country: United States
facility: Furiex Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Furiex Research Site
state: Florida
city: Oviedo
country: United States
facility: Furiex Research Site
state: Florida
city: Palm Beach
country: United States
facility: Furiex Research Site
state: Florida
city: Pinellas Park
country: United States
facility: Furiex Research Site
state: Florida
city: Pinellas Park
country: United States
facility: Furiex Research Site
state: Florida
city: Port Orange
country: United States
facility: Furiex Research Site
state: Florida
city: Sanford
country: United States
facility: Furiex Research Site
state: Florida
city: Sebastian
country: United States
facility: Furiex Research Site
state: Florida
city: South Miami
country: United States
facility: Furiex Research Site
state: Florida
city: Tampa
country: United States
facility: Furiex Research Site
state: Florida
city: Tampa
country: United States
facility: Furiex Research Site
state: Florida
city: Venice
country: United States
facility: Furiex Research Site
state: Florida
city: Wellington
country: United States
facility: Furiex Research Site
state: Florida
city: Winter Haven
country: United States
facility: Furiex Research Site
state: Florida
city: Winter Park
country: United States
facility: Furiex Research Site
state: Florida
city: Atlanta
country: United States
facility: Furiex Research Site
state: Georgia
city: Blue Ridge
country: United States
facility: Furiex Research Site
state: Georgia
city: Johns Creek
country: United States
facility: Furiex Research Site
state: Georgia
city: Lilburn
country: United States
facility: Furiex Research Site
state: Georgia
city: Oakwood
country: United States
facility: Furiex Research Site
state: Georgia
city: Perry
country: United States
facility: Furiex Research Site
state: Georgia
city: Snellville
country: United States
facility: Furiex Research Site
state: Georgia
city: Eagle
country: United States
facility: Furiex Research Site
state: Idaho
city: Addison
country: United States
facility: Furiex Research Site
state: Illinois
city: Chicago
country: United States
facility: Furiex Research Site
state: Illinois
city: Morton
country: United States
facility: Furiex Research Site
state: Illinois
city: Brownsburg
country: United States
facility: Furiex Research Site
state: Indiana
city: Evansville
country: United States
facility: Furiex Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Furiex Research Site
state: Indiana
city: Clive
country: United States
facility: Furiex Research Site
state: Iowa
city: Davenport
country: United States
facility: Furiex Research Site
state: Iowa
city: Iowa City
country: United States
facility: Furiex Research Site
state: Iowa
city: West Des Moines
country: United States
facility: Furiex Research Site
state: Iowa
city: Newton
country: United States
facility: Furiex Research Site
state: Kansas
city: Prairie Village
country: United States
facility: Furiex Research Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Furiex Research Site
state: Kansas
city: Wichita
country: United States
facility: Furiex Research Site
state: Kansas
city: Wichita
country: United States
facility: Furiex Research Site
state: Kansas
city: Crestview Hills
country: United States
facility: Furiex Research Site
state: Kentucky
city: Hawesville
country: United States
facility: Furiex Research Site
state: Kentucky
city: Lexington
country: United States
facility: Furiex Research Site
state: Kentucky
city: Lexington
country: United States
facility: Furiex Research Site
state: Kentucky
city: Louisville
country: United States
facility: Furiex Research Site
state: Kentucky
city: Madisonville
country: United States
facility: Furiex Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Furiex Research Site
state: Kentucky
city: Baker
country: United States
facility: Furiex Research Site
state: Louisiana
city: Covington
country: United States
facility: Furiex Research Site
state: Louisiana
city: Hammond
country: United States
facility: Furiex Research Site
state: Louisiana
city: Metairie
country: United States
facility: Furiex Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Furiex Research Site
state: Louisiana
city: Opelousas
country: United States
facility: Furiex Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Furiex Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Furiex Research Site
state: Louisiana
city: Bangor
country: United States
facility: Furiex Research Site
state: Maine
city: Annapolis
country: United States
facility: Furiex Research Site
state: Maryland
city: Chevy Chase
country: United States
facility: Furiex Research Site
state: Maryland
city: Brockton
country: United States
facility: Furiex Research Site
state: Massachusetts
city: Watertown
country: United States
facility: Furiex Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Furiex Research Site
state: Michigan
city: Southfield
country: United States
facility: Furiex Research Site
state: Michigan
city: Stevensville
country: United States
facility: Furiex Research Site
state: Michigan
city: Chaska
country: United States
facility: Furiex Research Site
state: Minnesota
city: Jackson
country: United States
facility: Furiex Research Site
state: Mississippi
city: Jefferson City
country: United States
facility: Furiex Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Furiex Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Furiex Research Site
state: Missouri
city: Saint Peters
country: United States
facility: Furiex Research Site
state: Missouri
city: Billings
country: United States
facility: Furiex Research Site
state: Montana
city: Bellevue
country: United States
facility: Furiex Research Site
state: Nebraska
city: Omaha
country: United States
facility: Furiex Research Site
state: Nebraska
city: Omaha
country: United States
facility: Furiex Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Furiex Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Furiex Research Site
state: Nevada
city: Collingswood
country: United States
facility: Furiex Research Site
state: New Jersey
city: Edison
country: United States
facility: Furiex Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Furiex Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Furiex Research Site
state: New York
city: Endwell
country: United States
facility: Furiex Research Site
state: New York
city: Great Neck
country: United States
facility: Furiex Research Site
state: New York
city: Hartsdale
country: United States
facility: Furiex Research Site
state: New York
city: Kew Gardens
country: United States
facility: Furiex Research Site
state: New York
city: New Windsor
country: United States
facility: Furiex Research Site
state: New York
city: New York
country: United States
facility: Furiex Research Site
state: New York
city: North Massapequa
country: United States
facility: Furiex Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Furiex Research Site
state: New York
city: Asheville
country: United States
facility: Furiex Research Site
state: North Carolina
city: Asheville
country: United States
facility: Furiex Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Furiex Research Site
state: North Carolina
city: Durham
country: United States
facility: Furiex Research Site
state: North Carolina
city: Fayetteville
country: United States
facility: Furiex Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Furiex Research Site
state: North Carolina
city: Hickory
country: United States
facility: Furiex Research Site
state: North Carolina
city: High Point
country: United States
facility: Furiex Research Site
state: North Carolina
city: Kinston
country: United States
facility: Furiex Research Site
state: North Carolina
city: Lenoir
country: United States
facility: Furiex Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Furiex Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Furiex Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Furiex Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Furiex Research Site
state: North Carolina
city: Fargo
country: United States
facility: Furiex Research Site
state: North Dakota
city: Fargo
country: United States
facility: Furiex Research Site
state: North Dakota
city: Beavercreek
country: United States
facility: Furiex Research Site
state: Ohio
city: Berea
country: United States
facility: Furiex Research Site
state: Ohio
city: Centerville
country: United States
facility: Furiex Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Furiex Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Furiex Research Site
state: Ohio
city: Columbus
country: United States
facility: Furiex Research Site
state: Ohio
city: Dayton
country: United States
facility: Furiex Research Site
state: Ohio
city: Dayton
country: United States
facility: Furiex Research Site
state: Ohio
city: Englewood
country: United States
facility: Furiex Research Site
state: Ohio
city: Franklin
country: United States
facility: Furiex Research Site
state: Ohio
city: Marion
country: United States
facility: Furiex Research Site
state: Ohio
city: Miamisburg
country: United States
facility: Furiex Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Furiex Research Site
state: Ohio
city: Wadsworth
country: United States
facility: Furiex Research Site
state: Ohio
city: Zanesville
country: United States
facility: Furiex Research Site
state: Ohio
city: Tulsa
country: United States
facility: Furiex Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Furiex Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Furiex Research Site
state: Oklahoma
city: Belle Vernon
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Cumberland
country: United States
facility: Furiex Research Site
state: Rhode Island
city: East Providence
country: United States
facility: Furiex Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Furiex Research Site
state: South Carolina
city: Charleston
country: United States
facility: Furiex Research Site
state: South Carolina
city: Fort Mill
country: United States
facility: Furiex Research Site
state: South Carolina
city: Greenville
country: United States
facility: Furiex Research Site
state: South Carolina
city: Greer
country: United States
facility: Furiex Research Site
state: South Carolina
city: Greer
country: United States
facility: Furiex Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Furiex Research Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Furiex Research Site
state: South Carolina
city: Simpsonville
country: United States
facility: Furiex Research Site
state: South Carolina
city: Summerville
country: United States
facility: Furiex Research Site
state: South Carolina
city: Bristol
country: United States
facility: Furiex Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Furiex Research Site
state: Tennessee
city: Clarksville
country: United States
facility: Furiex Research Site
state: Tennessee
city: Columbia
country: United States
facility: Furiex Research Site
state: Tennessee
city: Franklin
country: United States
facility: Furiex Research Site
state: Tennessee
city: Johnson City
country: United States
facility: Furiex Research Site
state: Tennessee
city: Memphis
country: United States
facility: Furiex Research Site
state: Tennessee
city: Smyrna
country: United States
facility: Furiex Research Site
state: Tennessee
city: Austin
country: United States
facility: Furiex Research Site
state: Texas
city: Austin
country: United States
facility: Furiex Research Site
state: Texas
city: Baytown
country: United States
facility: Furiex Research Site
state: Texas
city: Beaumont
country: United States
facility: Furiex Research Site
state: Texas
city: Dallas
country: United States
facility: Furiex Research Site
state: Texas
city: El Paso
country: United States
facility: Furiex Research Site
state: Texas
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Marshall
country: United States
facility: Furiex Research Site
state: Texas
city: Plano
country: United States
facility: Furiex Research Site
state: Texas
city: San Antonio
country: United States
facility: Furiex Research Site
state: Texas
city: San Antonio
country: United States
facility: Furiex Research Site
state: Texas
city: San Antonio
country: United States
facility: Furiex Research Site
state: Texas
city: Sugar Land
country: United States
facility: Furiex Research Site
state: Texas
city: Clinton
country: United States
facility: Furiex Research Site
state: Utah
city: Draper
country: United States
facility: Furiex Research Site
state: Utah
city: Logan
country: United States
facility: Furiex Research Site
state: Utah
city: Ogden
country: United States
facility: Furiex Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Furiex Research Site
state: Utah
city: West Jordan
country: United States
facility: Furiex Research Site
state: Utah
city: Lynchburg
country: United States
facility: Furiex Research Site
state: Virginia
city: Richmond
country: United States
facility: Furiex Research Site
state: Virginia
city: Williamsburg
country: United States
facility: Furiex Research Site
state: Virginia
city: Spokane
country: United States
facility: Furiex Research Site
state: Washington
city: Spokane
country: United States
facility: Furiex Research Site
state: Washington
city: Spokane
country: United States
facility: Furiex Research Site
state: Washington
city: Wenatchee
country: United States
facility: Furiex Research Site
state: Washington
city: Morgantown
country: United States
facility: Furiex Research Site
state: West Virginia
city: Wauwatosa
country: United States
facility: Furiex Research Site
state: Wisconsin
city: Kamloops
country: Canada
facility: Furiex Research Site
state: British Columbia
city: Kelowna
country: Canada
facility: Furiex Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Furiex Research Site
state: Manitoba
city: Bridgewater
country: Canada
facility: Furiex Research Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Furiex Research Site
state: Nova Scotia
city: Cambridge
country: Canada
facility: Furiex Research Site
state: Ontario
city: London
country: Canada
facility: Furiex Research Site
state: Ontario
city: Niagara Falls
country: Canada
facility: Furiex Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Furiex Research Site
state: Ontario
city: Chesterfield
country: United Kingdom
facility: Furiex Research Site
state: Derbyshire
city: Blackpool
country: United Kingdom
facility: Furiex Research Site
state: Lancashire
city: Thornton-Cleveleys
country: United Kingdom
facility: Furiex Research Site
state: Lancashire
city: Burbage
country: United Kingdom
facility: Furiex Research Site
state: Leicestershire
city: Leamington Spa
country: United Kingdom
facility: Furiex Research Site
state: Warwickshire
city: Chippenham
country: United Kingdom
facility: Furiex Research Site
state: Wiltshire
city: Bath
country: United Kingdom
facility: Furiex Research Site
city: Bath
country: United Kingdom
facility: Furiex Research Site
city: Coventry
country: United Kingdom
facility: Furiex Research Site
city: Dorking
country: United Kingdom
facility: Furiex Research Site
city: Haxey
country: United Kingdom
facility: Furiex Research Site
city: London
country: United Kingdom
facility: Furiex Research Site
city: Shrewsbury
country: United Kingdom
facility: Furiex Research Site
city: Southampton
country: United Kingdom
facility: Furiex Research Site
city: Strensall
country: United Kingdom
facility: Furiex Research Site
city: Thornton
country: United Kingdom
facility: Furiex Research Site
city: Torpoint
country: United Kingdom
facility: Furiex Research Site
Study officials:
References:
citation: Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
citation: Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.