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

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

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

Study Overview

• Status: Completed
• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Asimadoline

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.

• Study Type: Interventional
• Enrollment (Actual): 611
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Birmingham, Alabama, United States, 35213
      • Alliance Clinical Research
    • Huntsville, Alabama, United States, 35801
      • Medical Affliated Research Center, Inc.
    • Huntsville, Alabama, United States, 35801
      • Saadat Ansari MD LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Connect Clinical Research Center
    • Scottsdale, Arizona, United States, 85260
      • Digestive Health Research Unit
    • Tucson, Arizona, United States, 85741
      • Genova Clinical Research
    • Tucson, Arizona, United States, 85715
      • Acrc/Arizona Clinical Research Center, Inc.
    • Tucson, Arizona, United States, 85712
      • Adobe Clinical Research, LLC
    • Tucson, Arizona, United States, 85741
      • W/C Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
    • Sherwood, Arkansas, United States, 72120
      • Arkansas Gastroenterology
  • California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Chula Vista, California, United States, 91910
      • GW Research Inc,
    • Chula Vista, California, United States, 91911
      • La Jolla Clinical Research, Inc
    • Encinitas, California, United States, 92024
      • Discovery Clinical Research
    • Garden Grove, California, United States, 92840
      • Digestive & Liver Disease Specialist
    • Long Beach, California, United States, 90808
      • Collaborative Neuroscience Network Inc
    • Madera, California, United States, 93637
      • California Gastroenterology Associates
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Sacramento, California, United States, 95816
      • Sutter Medical Group Gastroenterology
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • Westlake Village, California, United States, 91361
      • Westlake Medical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Lynne Institute of the Rockies
    • Littleton, Colorado, United States, 80120
      • Arapahoe Gastroenterology
    • Pueblo, Colorado, United States, 81008
      • Lynn Institute of Pueblo
    • Thornton, Colorado, United States, 80229
      • Rocky Mountain Gastroenterology Associates
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Clinical Research, LLC
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Consultants for Clinical Research of South Florida
    • Brookville, Florida, United States, 34601
      • Meridien Research
    • Coral Gables, Florida, United States, 33134
      • BioPharma Research
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Hialeah, Florida, United States, 33012
      • A.G.A. Clinical Trials
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Maitland, Florida, United States, 32751
      • Center For Advanced Gastroenterology
    • Miami, Florida, United States, 33166
      • FIRC
    • Pinellas Park, Florida, United States, 33782
      • DMI Research
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Sanford, Florida, United States, 32771
      • International Clinical Research-US,LLC
    • Summerfield, Florida, United States, 34491
      • Lakeview Medical Research
    • Wellington, Florida, United States, 33414
      • Venra Clinical Studies, LLC
    • Winter Park, Florida, United States, 32792
      • Alliance Clinical Research
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Center For Gastroenterology
    • Hartwell, Georgia, United States, 30643
      • Tri County Research
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Gastroenterologist S.C.
    • Chicago, Illinois, United States, 60622
      • Illinois Center for Clinical Research
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Elkhart Clinic, LLC/Indiana Medical Research, LLC
    • Evansville, Indiana, United States, 47714
      • MediSphere Medical Research Center, LLC
  • Iowa
    • Clive, Iowa, United States, 50325
      • Mercy Gastroenterology Clinic
    • Davenport, Iowa, United States, 52807
      • Gastrointestinal Clinic of Quad Cities
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves-Gilbert Clinic
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Associates, PSC
    • Hebron, Kentucky, United States, 41048
      • Hometown Urgent Care and Research
    • Lexington, Kentucky, United States, 40504
      • The Research Group of Lexington, LLC
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Medical-Dental Complex
    • Madisonville, Kentucky, United States, 42431
      • Tover Health Systems Center for Clinical Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Investigative Clinical Research
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Resarch
    • Towson, Maryland, United States, 21204
      • Spectrum Clinical Research Inc.
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
    • Fall River, Massachusetts, United States, 02720
      • NECCR Internal Medicine and Cardiology Associates LLC
    • Haverhill, Massachusetts, United States, 01830
      • ActivMed Practices and Research
  • Michigan
    • Ann Arbor, Michigan, United States, 48009
      • University of Michigan Health System
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Accociates, PA
    • Tupelo, Mississippi, United States, 38801
      • Digestive Research Specialist
  • Missouri
    • Lees Summit, Missouri, United States, 64064
      • Midwest Center For Clinical Research
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases, Inc.
    • St. Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Dr. Meera Dewan PC
  • New Jersey
    • Edison, New Jersey, United States, 08817
      • Anderson & Collins Clinical Research
    • Marlton, New Jersey, United States, 08053
      • South Jersey Gastroenterology. P.A.
    • Morristown, New Jersey, United States, 07960
      • Atlantic Research Affiliates
  • New York
    • Brooklyn, New York, United States, 11206
      • Life Medi-Research
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates, LLP
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital Clinical Trials Center
    • New York,, New York, United States, 10075
      • Research Associates of New York
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley
    • Setauket, New York, United States, 11733
      • Gastrointestinal Research Associates, LLC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The UNC Center for Functional GI and Motility Disorders
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte, LLC
    • Greensboro, North Carolina, United States, 27403
      • LeBauer Research Associates, P.A.
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Kinston, North Carolina, United States, 28501
      • Kinston Medical Specialist, P.A.
    • Raleigh, North Carolina, United States, 27616
      • Wake Research Associates
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research LLC
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron Gastroenterology Associates
    • Cincinnati, Ohio, United States, 45242
      • Gastroenterology Research Consultants of Greater Cincinnati
    • Columbus, Ohio, United States, 43214
      • Hometown Urgent Care
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care
    • Groveport, Ohio, United States, 43125
      • Hometown Urgent Care and Research
    • Miamisburg, Ohio, United States, 45342
      • Hometown Urgent Care and Research
    • Zanesville, Ohio, United States, 43701
      • Physicians Research, Inc
  • Oklahoma
    • Duncan, Oklahoma, United States, 73533
      • Journey Clinical Research
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Foundation for Digestive Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Gastroenterology Clinic, LLC
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Safe Harbor Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Southeast Medical Research
    • Columbia, South Carolina, United States, 29201
      • SC Clinical Research, LLC
    • Goose Creek, South Carolina, United States, 29445
      • Coastal Carolina Research Center in Goose Creek
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research, LLC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Midwest Medical Care
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Gastroenterology Associates
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Clarksville, Tennessee, United States, 37043
      • Alpha Clinical Research
    • Germantown, Tennessee, United States, 38138
      • Memphis Gastroenterology Group
    • Hermitage, Tennessee, United States, 37076
      • Associates in Gastroenterology
    • Kingsport, Tennessee, United States, 37660
      • Gastroenterology Associates Clinical Research
    • Nashville, Tennessee, United States, 37203
      • Columbia Medical Group -The First Clinic, Inc.
    • Nashville, Tennessee, United States, 37205
      • Dial Research Associates, Inc
    • Spring Hill, Tennessee, United States, 37147
      • Tn Medical Research
  • Texas
    • Carrollton, Texas, United States, 75010
      • Research Across America/ Family Medicine Associates of Texas
    • Corsicana, Texas, United States, 75110
      • Corsicana Medical Research, PLLC
    • El Paso, Texas, United States, 79905
      • Texas University Health Sciences Center
    • Houston, Texas, United States, 77034
      • Gastroenterology Consultants, P.A.
    • Houston, Texas, United States, 77079
      • Houston S. Endoscopy and Research Center
    • Houston, Texas, United States, 77098
      • Pioneer Research Solutions, Inc
    • Plano, Texas, United States, 75075
      • Digestive Health Associates of Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
  • Utah
    • Clinton, Utah, United States, 84015
      • Advanced Research Institute
    • Logan, Utah, United States, 84341
      • Advanced Research Institute
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Sandy, Utah, United States, 84094
      • Advanced Research Institute
  • Virginia
    • Virginia Beach, Virginia, United States, 23454
      • Gastroenterology, Ltd.
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Treatment; 0.5 mg asimadoline bid	Drug: Asimadoline; 0.5 mg Asimadoline BID; Other Names: EMD 61 753; EMR 63 320

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the two treatment groups with respect to IBS-related abdominal pain		Up to 12 weeks
Compare the two treatment groups with respect to stool frequency		Up to 12 weeks
Compare the two treatment groups with respect to stool urgency		Up to 12 weeks
Compare the two treatment groups with respect to IBS symptoms		up to 12 weeks
Compare the two treatment groups with respect to stool consistency scores	Using the Bristol Stool Form Scale	Up to 12 weeks
Incidence of adverse events as a measure of tolerability		Up to 16 weeks
Abnormalities of laboratory tests as a measure of tolerability		Up to 16 weeks

Collaborators and Investigators

• Sponsor: Tioga Pharmaceuticals
• Collaborators: RTI Health Solutions
• Investigators: Study Chair: Allen Mangel, M.D.Ph.D., CMO

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: diarrhea predominant irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: ASMP3001