Clinical trial NCT01130272: Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome with diarrhea
Irritable bowel syndrome
Diarrhea predominant irritable bowel syndrome
Colonic diseases
Colonic diseases, functional
Digestive system disease
Gastrointestinal disease
Intestinal disease
Colonic pseudo-obstruction
Diarrhea
Signs and Symptoms, Digestive
Lead sponsor: Furiex Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).


Eligibility criteria: Key Inclusion Criteria:

* Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
* Female patients must be:
* postmenopausal, defined as amenorrhea 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.

Key Exclusion Criteria:

* Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
* Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
* Patient has a history of diverticulitis within 6 months prior to Prescreening
* Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

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 at Week 4
timeFrame: Baseline (Week prior to Randomization) to Week 4
measure: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12
timeFrame: Baseline (Week prior to Randomization) to Week 12
Secondary outcomes:
measure: Change From Baseline in the Weekly Pain Scores
timeFrame: Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
measure: Change From Baseline in Weekly BSS Scores
timeFrame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
measure: Change From Baseline in the Number of Daily Bowel Movements
timeFrame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
measure: Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time
timeFrame: Baseline (Week Prior to Randomization) to Weeks 1-12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Furiex Research Site
state: Alabama
city: Birmingham
country: United States
facility: Furiex Research Site
state: Alabama
city: Birmingham
country: United States
facility: Furiex Research Site
state: Alabama
city: Dothan
country: United States
facility: Furiex Research Site
state: Alabama
city: Huntsville
country: United States
facility: Furiex Research Site
state: Alabama
city: Huntsville
country: United States
facility: Furiex Research Site
state: Alabama
city: Mobile
country: United States
facility: Furiex Research Site
state: Alabama
city: Montgomery
country: United States
facility: Furiex Research Site
state: Alabama
city: Pell City
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: Phoenix
country: United States
facility: Furiex Research Site
state: Arizona
city: Phoenix
country: United States
facility: Furiex Research Site
state: Arizona
city: Tempe
country: United States
facility: Furiex Research Site
state: Arizona
city: Tempe
country: United States
facility: Furiex Research Site
state: Arizona
city: Tucson
country: United States
facility: Furiex Research Site
state: Arizona
city: Tucson
country: United States
facility: Furiex Research Site
state: Arizona
city: Jonesboro
country: United States
facility: Furiex Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Furiex Research Site
state: Arkansas
city: Searcy
country: United States
facility: Furiex Research Site
state: Arkansas
city: Sherwood
country: United States
facility: Furiex Research Site
state: Arkansas
city: Aliso Viejo
country: United States
facility: Furiex Research Site
state: California
city: Anaheim
country: United States
facility: Furiex Research Site
state: California
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country: United States
facility: Furiex Research Site
state: California
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country: United States
facility: Furiex Research Site
state: California
city: Carlsbad
country: United States
facility: Furiex Research Site
state: California
city: Encinitas
country: United States
facility: Furiex Research Site
state: California
city: Garden Grove
country: United States
facility: Furiex Research Site
state: California
city: Garden Grove
country: United States
facility: Furiex Research Site
state: California
city: Inglewood
country: United States
facility: Furiex Research Site
state: California
city: Laguna Hills
country: United States
facility: Furiex Research Site
state: California
city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
facility: Furiex Research Site
state: California
city: Los Angeles
country: United States
facility: Furiex Research Site
state: California
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country: United States
facility: Furiex Research Site
state: California
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country: United States
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facility: Furiex Research Site
state: California
city: San Diego
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country: United States
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city: Colorado Springs
country: United States
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city: Colorado Springs
country: United States
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state: Colorado
city: Colorado Springs
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city: Denver
country: United States
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country: United States
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state: Colorado
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country: United States
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state: Colorado
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city: Waterbury
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state: Connecticut
city: Aventura
country: United States
facility: Furiex Research Site
state: Florida
city: Boca Raton
country: United States
facility: Furiex Research Site
state: Florida
city: Boca Raton
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state: Florida
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state: Florida
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state: Florida
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state: Florida
city: Fort Lauderdale
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state: Florida
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state: Florida
city: Hialeah
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state: Florida
city: Jacksonville
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state: Florida
city: Jacksonville
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state: Florida
city: Jupiter
country: United States
facility: Furiex Research Site
state: Florida
city: Kissimmee
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state: Florida
city: Largo
country: United States
facility: Furiex Research Site
state: Florida
city: Lauderdale Lakes
country: United States
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state: Florida
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state: Florida
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city: Miami
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city: Miami
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state: Georgia
city: Atlanta
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state: Georgia
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facility: Furiex Research Site
state: Georgia
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state: Georgia
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state: Georgia
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state: Georgia
city: Rome
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state: Georgia
city: Sandy Springs
country: United States
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city: Savannah
country: United States
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state: Georgia
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state: Idaho
city: Boise
country: United States
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state: Idaho
city: Idaho Falls
country: United States
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state: Idaho
city: Meridian
country: United States
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state: Idaho
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state: Idaho
city: Champaign
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: Anderson
country: United States
facility: Furiex Research Site
state: Indiana
city: Bloomington
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: Indianapolis
country: United States
facility: Furiex Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Furiex Research Site
state: Indiana
city: Lenexa
country: United States
facility: Furiex Research Site
state: Kansas
city: Mission
country: United States
facility: Furiex Research Site
state: Kansas
city: Overland Park
country: United States
facility: Furiex Research Site
state: Kansas
city: Overland Park
country: United States
facility: Furiex Research Site
state: Kansas
city: Topeka
country: United States
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state: Kansas
city: Wichita
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state: Kansas
city: Bowling Green
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state: Kentucky
city: Lexington
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state: Kentucky
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state: Kentucky
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country: United States
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state: Louisiana
city: Monroe
country: United States
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state: Louisiana
city: Opelousas
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Shreveport
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state: Louisiana
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state: Maryland
city: Chevy Chase
country: United States
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state: Maryland
city: Hollywood
country: United States
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state: Maryland
city: Laurel
country: United States
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state: Maryland
city: Lutherville
country: United States
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state: Maryland
city: Prince Frederick
country: United States
facility: Furiex Research Site
state: Maryland
city: Rockville
country: United States
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state: Massachusetts
city: Boston
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state: Massachusetts
city: Boston
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state: Massachusetts
city: Brockton
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state: Massachusetts
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state: Massachusetts
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state: Massachusetts
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country: United States
facility: Furiex Research Site
state: Michigan
city: Kalamazoo
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facility: Furiex Research Site
state: Michigan
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country: United States
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state: Michigan
city: Troy
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state: Michigan
city: Chaska
country: United States
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state: Minnesota
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country: United States
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state: Mississippi
city: Tupelo
country: United States
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state: Mississippi
city: Mexico
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: Bozeman
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: Henderson
country: United States
facility: Furiex Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Furiex Research Site
state: Nevada
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state: Nevada
city: Atco
country: United States
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country: United States
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state: New Jersey
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state: New Jersey
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state: New York
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state: North Carolina
city: Winston-Salem
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state: North Carolina
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city: Fargo
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state: Ohio
city: Beachwood
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state: Oklahoma
city: Norman
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state: Oklahoma
city: Oklahoma City
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state: Oklahoma
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city: Yukon
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state: Pennsylvania
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city: Johnson City
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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: San Antonio
country: United States
facility: Furiex Research Site
state: Texas
city: Sugar Land
country: United States
facility: Furiex Research Site
state: Texas
city: Sugar Land
country: United States
facility: Furiex Research Site
state: Texas
city: Webster
country: United States
facility: Furiex Research Site
state: Texas
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: Salt Lake City
country: United States
facility: Furiex Research Site
state: Utah
city: South Jordan
country: United States
facility: Furiex Research Site
state: Utah
city: West Jordan
country: United States
facility: Furiex Research Site
state: Utah
city: West Valley City
country: United States
facility: Furiex Research Site
state: Utah
city: Alexandria
country: United States
facility: Furiex Research Site
state: Virginia
city: Chesapeake
country: United States
facility: Furiex Research Site
state: Virginia
city: Christiansburg
country: United States
facility: Furiex Research Site
state: Virginia
city: Danville
country: United States
facility: Furiex Research Site
state: Virginia
city: Fairfax
country: United States
facility: Furiex Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Furiex Research Site
state: Virginia
city: Mill Creek
country: United States
facility: Furiex Research Site
state: Washington
city: Madison
country: United States
facility: Furiex Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Furiex Research Site
state: Wisconsin
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: Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
citation: Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.