Clinical trial NCT01100684: Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Keywords: diarrhea predominant irritable bowel syndrome
Lead sponsor: Tioga Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2010-04-09
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
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 whether asimadoline is safe and effective at treating D-IBS.

Detailed description: The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters:

* Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score
* Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an "overall study responder," defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.

Eligibility criteria: Inclusion Criteria:

1. Signs and dates a written informed consent form.
2. Male and female subjects aged 18-79 who are fluent in English
3. All subjects must use protocol specified contraceptive measures
4. The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms:

   Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool
5. The subject has been diagnosed with diarrhea-predominant IBS
6. Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm.

Exclusion Criteria:

1. The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract.
2. Subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
3. The subject has a family history of prolonged QT syndrome.
4. The subject has been diagnosed with a major psychiatric disorder.
5. The subject has a history of alcohol or substance abuse within the past 2 years.
6. The subject has a history or current evidence of laxative abuse
7. The subject has a positive stool sample for ova or parasite.
8. The subject has used an investigational drug or participated in an investigational study within 30 days of screening.
9. The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
10. The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit.
11. The subject is a pregnant woman or a woman who is breast feeding.
12. The subject is unable or unwilling to follow directions or use the electronic diary system.

Primary outcomes:
measure: 12 Week Abdominal Pain and Stool (APS) Frequency Responder
timeFrame: Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder
Secondary outcomes:
measure: Compare the two treatment groups with respect to IBS-related abdominal pain
timeFrame: Up to 12 weeks
measure: Compare the two treatment groups with respect to stool frequency
timeFrame: Up to 12 weeks
measure: Compare the two treatment groups with respect to stool urgency
timeFrame: Up to 12 weeks
measure: Compare the two treatment groups with respect to IBS symptoms
timeFrame: up to 12 weeks
measure: Compare the two treatment groups with respect to stool consistency scores
timeFrame: Up to 12 weeks
measure: Incidence of adverse events as a measure of tolerability
timeFrame: Up to 16 weeks
measure: Abnormalities of laboratory tests as a measure of tolerability
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Huntsville
country: United States
facility: Medical Affliated Research Center, Inc.
state: Alabama
city: Huntsville
country: United States
facility: Saadat Ansari MD LLC
state: Alabama
city: Chandler
country: United States
facility: Connect Clinical Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Digestive Health Research Unit
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: ACRC/Arizona Clinical Research Center, Inc.
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Tucson
country: United States
facility: W/C Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Chula Vista
country: United States
facility: GW Research Inc,
state: California
city: Chula Vista
country: United States
facility: La Jolla Clinical Research, Inc
state: California
city: Encinitas
country: United States
facility: Discovery Clinical Research
state: California
city: Garden Grove
country: United States
facility: Digestive & Liver Disease Specialist
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network Inc
state: California
city: Madera
country: United States
facility: California Gastroenterology Associates
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group Gastroenterology
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Colorado Springs
country: United States
facility: Lynne Institute of the Rockies
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastroenterology
state: Colorado
city: Pueblo
country: United States
facility: Lynn Institute of Pueblo
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Danbury
country: United States
facility: Danbury Clinical Research, LLC
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of South Florida
state: Florida
city: Brookville
country: United States
facility: Meridien Research
state: Florida
city: Coral Gables
country: United States
facility: BioPharma Research
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Hialeah
country: United States
facility: A.G.A. Clinical Trials
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Maitland
country: United States
facility: Center for Advanced Gastroenterology
state: Florida
city: Miami
country: United States
facility: FIRC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Sanford
country: United States
facility: International Clinical Research-US,LLC
state: Florida
city: Summerfield
country: United States
facility: Lakeview Medical Research
state: Florida
city: Wellington
country: United States
facility: Venra Clinical Studies, LLC
state: Florida
city: Winter Park
country: United States
facility: Alliance Clinical Research
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology
state: Georgia
city: Hartwell
country: United States
facility: Tri County Research
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologist S.C.
state: Illinois
city: Chicago
country: United States
facility: Illinois Center for Clinical Research
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC/Indiana Medical Research, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Clive
country: United States
facility: Mercy Gastroenterology Clinic
state: Iowa
city: Davenport
country: United States
facility: Gastrointestinal Clinic of Quad Cities
state: Iowa
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates, PSC
state: Kentucky
city: Hebron
country: United States
facility: Hometown Urgent Care and Research
state: Kentucky
city: Lexington
country: United States
facility: The Research Group of Lexington, LLC
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Medical-Dental Complex
state: Kentucky
city: Madisonville
country: United States
facility: Tover Health Systems Center for Clinical Research
state: Kentucky
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Resarch
state: Maryland
city: Towson
country: United States
facility: Spectrum Clinical Research Inc.
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Fall River
country: United States
facility: NECCR Internal Medicine and Cardiology Associates LLC
state: Massachusetts
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestinal Accociates, PA
state: Mississippi
city: Tupelo
country: United States
facility: Digestive Research Specialist
state: Mississippi
city: Lees Summit
country: United States
facility: Midwest Center for Clinical Research
state: Missouri
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases, Inc.
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute, Inc.
state: Montana
city: Omaha
country: United States
facility: Dr. Meera Dewan PC
state: Nebraska
city: Edison
country: United States
facility: Anderson & Collins Clinical Research
state: New Jersey
city: Marlton
country: United States
facility: South Jersey Gastroenterology. P.A.
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Research Affiliates
state: New Jersey
city: Brooklyn
country: United States
facility: Life Medi-Research
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital Clinical Trials Center
state: New York
city: New York,
country: United States
facility: Research Associates of New York
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Setauket
country: United States
facility: Gastrointestinal Research Associates, LLC
state: New York
city: Chapel Hill
country: United States
facility: The UNC Center for Functional GI and Motility Disorders
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, P.A.
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialist, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Akron
country: United States
facility: Akron Gastroenterology Associates
state: Ohio
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Groveport
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Miamisburg
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Zanesville
country: United States
facility: Physicians Research, Inc
state: Ohio
city: Duncan
country: United States
facility: Journey Clinical Research
state: Oklahoma
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic, LLC
state: Oregon
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Charleston
country: United States
facility: Southeast Medical Research
state: South Carolina
city: Columbia
country: United States
facility: SC Clinical Research, LLC
state: South Carolina
city: Goose Creek
country: United States
facility: Coastal Carolina Research Center in Goose Creek
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Sioux Falls
country: United States
facility: Midwest Medical Care
state: South Dakota
city: Bristol
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Clarksville
country: United States
facility: Alpha Clinical Research
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Columbia Medical Group -The First Clinic, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Dial Research Associates, INC
state: Tennessee
city: Spring Hill
country: United States
facility: TN Medical Research
state: Tennessee
city: Carrollton
country: United States
facility: Research Across America/ Family Medicine Associates of Texas
state: Texas
city: Corsicana
country: United States
facility: Corsicana Medical Research, PLLC
state: Texas
city: El Paso
country: United States
facility: Texas University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Gastroenterology Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Houston S. Endoscopy and Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc
state: Texas
city: Plano
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Clinton
country: United States
facility: Advanced Research Institute
state: Utah
city: Logan
country: United States
facility: Advanced Research Institute
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Sandy
country: United States
facility: Advanced Research Institute
state: Utah
city: Virginia Beach
country: United States
facility: Gastroenterology, Ltd.
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: CMO
name: Allen Mangel, M.D.Ph.D.
role: STUDY_CHAIR
References: