Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial

Official title:

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100684
• Other study ID #: ASMP3001
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2010
• Last updated: December 17, 2013
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Tioga Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Asimadoline
0.5 mg Asimadoline BID
• Placebo
Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Tioga Pharmaceuticals	RTI Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Week Abdominal Pain and Stool (APS) Frequency Responder	A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements	Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder	No
Secondary	Compare the two treatment groups with respect to IBS-related abdominal pain		Up to 12 weeks	No
Secondary	Compare the two treatment groups with respect to stool frequency		Up to 12 weeks	No
Secondary	Compare the two treatment groups with respect to stool urgency		Up to 12 weeks	No
Secondary	Compare the two treatment groups with respect to IBS symptoms		up to 12 weeks	No
Secondary	Compare the two treatment groups with respect to stool consistency scores	Using the Bristol Stool Form Scale	Up to 12 weeks	No
Secondary	Incidence of adverse events as a measure of tolerability		Up to 16 weeks	Yes
Secondary	Abnormalities of laboratory tests as a measure of tolerability		Up to 16 weeks	Yes