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Diarrhea Predominant Irritable Bowel SyndromePhase 3NCT01100684

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

A Phase 3 study testing Asimadoline in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Tioga Pharmaceuticals at 142 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 79 years
What is being tested?
Asimadoline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
611 participants
Where
142 sitesUnited States
Study dates
May 2010to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signs and dates a written informed consent form.
  • Male and female subjects aged 18-79 who are fluent in English
  • All subjects must use protocol specified contraceptive measures
  • 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
  • The subject has been diagnosed with diarrhea-predominant IBS
  • 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.

Who cannot join

  • The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract.
  • 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).
  • The subject has a family history of prolonged QT syndrome.
  • The subject has been diagnosed with a major psychiatric disorder.
  • The subject has a history of alcohol or substance abuse within the past 2 years.
  • The subject has a history or current evidence of laxative abuse
Show all 12Show fewer
  • The subject has a positive stool sample for ova or parasite.
  • The subject has used an investigational drug or participated in an investigational study within 30 days of screening.
  • The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
  • 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.
  • The subject is a pregnant woman or a woman who is breast feeding.
  • The subject is unable or unwilling to follow directions or use the electronic diary system.

Trial locations and contacts

142 sites in 1 country.

142 sites in 1 country

United States142 sites

  • Akron Gastroenterology Associates

    Akron, Ohio, 44302

  • University of Michigan Health System

    Ann Arbor, Michigan, 48009

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Northwest Gastroenterologist S.C.

    Arlington Heights, Illinois, 60005

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • Montana Health Research Institute, Inc.

    Billings, Montana, 59102

  • Alliance Clinical Research

    Birmingham, Alabama, 35213

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Consultants for Clinical Research of South Florida

    Boynton Beach, Florida, 33426

  • Gastroenterology Associates

    Bristol, Tennessee, 37620

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • Life Medi-Research

    Brooklyn, New York, 11206

  • Meridien Research

    Brookville, Florida, 34601

  • Providence Clinical Research

    Burbank, California, 91505

  • Research Across America/ Family Medicine Associates of Texas

    Carrollton, Texas, 75010

  • Connect Clinical Research Center

    Chandler, Arizona, 85224

  • The UNC Center for Functional GI and Motility Disorders

    Chapel Hill, North Carolina, 27599

  • Southeast Medical Research

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Illinois Center for Clinical Research

    Chicago, Illinois, 60622

  • GW Research Inc,

    Chula Vista, California, 91910

  • La Jolla Clinical Research, Inc

    Chula Vista, California, 91911

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio, 45242

  • Alpha Clinical Research

    Clarksville, Tennessee, 37043

  • Advanced Research Institute

    Clinton, Utah, 84015

  • Mercy Gastroenterology Clinic

    Clive, Iowa, 50325

  • Lynne Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • SC Clinical Research, LLC

    Columbia, South Carolina, 29201

  • Hometown Urgent Care

    Columbus, Ohio, 43214

  • BioPharma Research

    Coral Gables, Florida, 33134

  • Corsicana Medical Research, PLLC

    Corsicana, Texas, 75110

  • Tri-State Gastroenterology Associates, PSC

    Crestview Hills, Kentucky, 41017

  • Danbury Clinical Research, LLC

    Danbury, Connecticut, 06810

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Hometown Urgent Care

    Dayton, Ohio, 45432

  • Atlanta Center for Gastroenterology

    Decatur, Georgia, 30033

  • Journey Clinical Research

    Duncan, Oklahoma, 73533

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Anderson & Collins Clinical Research

    Edison, New Jersey, 08817

  • Texas University Health Sciences Center

    El Paso, Texas, 79905

  • Elkhart Clinic, LLC/Indiana Medical Research, LLC

    Elkhart, Indiana, 46514

  • Discovery Clinical Research

    Encinitas, California, 92024

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • NECCR Internal Medicine and Cardiology Associates LLC

    Fall River, Massachusetts, 02720

  • Lillestol Research LLC

    Fargo, North Dakota, 58103

  • Digestive & Liver Disease Specialist

    Garden Grove, California, 92840

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Coastal Carolina Research Center in Goose Creek

    Goose Creek, South Carolina, 29445

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • LeBauer Research Associates, P.A.

    Greensboro, North Carolina, 27403

  • Hometown Urgent Care and Research

    Groveport, Ohio, 43125

  • Meritus Center for Clinical Resarch

    Hagerstown, Maryland, 21742

  • Tri County Research

    Hartwell, Georgia, 30643

  • ActivMed Practices and Research

    Haverhill, Massachusetts, 01830

  • Hometown Urgent Care and Research

    Hebron, Kentucky, 41048

  • Associates in Gastroenterology

    Hermitage, Tennessee, 37076

  • A.G.A. Clinical Trials

    Hialeah, Florida, 33012

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Gastroenterology Consultants, P.A.

    Houston, Texas, 77034

  • Houston S. Endoscopy and Research Center

    Houston, Texas, 77079

  • Pioneer Research Solutions, Inc

    Houston, Texas, 77098

  • Medical Affliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Saadat Ansari MD LLC

    Huntsville, Alabama, 35801

  • Gastrointestinal Accociates, PA

    Jackson, Mississippi, 39202

  • Gastroenterology Associates Clinical Research

    Kingsport, Tennessee, 37660

  • Kinston Medical Specialist, P.A.

    Kinston, North Carolina, 28501

  • Altus Research

    Lake Worth, Florida, 33461

  • Midwest Center for Clinical Research

    Lees Summit, Missouri, 64064

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40504

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Arapahoe Gastroenterology

    Littleton, Colorado, 80120

  • Advanced Research Institute

    Logan, Utah, 84341

  • Collaborative Neuroscience Network Inc

    Long Beach, California, 90808

  • University of Louisville Medical-Dental Complex

    Louisville, Kentucky, 40202

  • California Gastroenterology Associates

    Madera, California, 93637

  • Tover Health Systems Center for Clinical Research

    Madisonville, Kentucky, 42431

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • South Jersey Gastroenterology. P.A.

    Marlton, New Jersey, 08053

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • FIRC

    Miami, Florida, 33166

  • Hometown Urgent Care and Research

    Miamisburg, Ohio, 45342

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital Clinical Trials Center

    Mineola, New York, 11501

  • Atlantic Research Affiliates

    Morristown, New Jersey, 07960

  • Columbia Medical Group -The First Clinic, Inc.

    Nashville, Tennessee, 37203

  • Dial Research Associates, INC

    Nashville, Tennessee, 37205

  • Research Associates of New York

    New York, New York, 10075

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Dr. Meera Dewan PC

    Omaha, Nebraska, 68144

  • Community Clinical Trials

    Orange, California, 92868

  • DMI Research

    Pinellas Park, Florida, 33782

  • Digestive Health Associates of Texas

    Plano, Texas, 75075

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Northwest Gastroenterology Clinic, LLC

    Portland, Oregon, 97210

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Lynn Institute of Pueblo

    Pueblo, Colorado, 81008

  • Wake Research Associates

    Raleigh, North Carolina, 27616

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Medical Group Gastroenterology

    Sacramento, California, 95816

  • Saginaw Valley Medical Research Group, LLC

    Saginaw, Michigan, 48604

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Advanced Research Institute

    Sandy City, Utah, 84094

  • International Clinical Research-US,LLC

    Sanford, Florida, 32771

  • Digestive Health Research Unit

    Scottsdale, Arizona, 85260

  • Gastrointestinal Research Associates, LLC

    Setauket, New York, 11733

  • Arkansas Gastroenterology

    Sherwood, Arkansas, 72120

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Midwest Medical Care

    Sioux Falls, South Dakota, 57108

  • TN Medical Research

    Spring Hill, Tennessee, 37147

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Lakeview Medical Research

    Summerfield, Florida, 34491

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado, 80229

  • Spectrum Clinical Research Inc.

    Towson, Maryland, 21204

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • ACRC/Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • Genova Clinical Research

    Tucson, Arizona, 85741

  • W/C Clinical Research

    Tucson, Arizona, 85741

  • Digestive Research Specialist

    Tupelo, Mississippi, 38801

  • Gastroenterology, Ltd.

    Virginia Beach, Virginia, 23454

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Venra Clinical Studies, LLC

    Wellington, Florida, 33414

  • Westlake Medical Research

    Westlake Village, California, 91361

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28403

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Alliance Clinical Research

    Winter Park, Florida, 32792

  • Physicians Research, Inc

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Asimadoline, Placebo
Keywords
diarrhea predominant irritable bowel syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AsimadolineDrug

    Also called EMD 61 753, EMR 63 320

    0.5 mg Asimadoline BID

  • PlaceboDrug

    Placebo

Study groups in NCT01100684
Study groupRoleWhat they receive
TreatmentExperimental0.5 mg asimadoline bid
Receives: Drug: Asimadoline
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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 (7)

  1. Compare the two treatment groups with respect to IBS-related abdominal pain

    Measured: Up to 12 weeks

  2. Compare the two treatment groups with respect to stool frequency

    Measured: Up to 12 weeks

  3. Compare the two treatment groups with respect to stool urgency

    Measured: Up to 12 weeks

  4. Compare the two treatment groups with respect to IBS symptoms

    Measured: up to 12 weeks

  5. Compare the two treatment groups with respect to stool consistency scores

    Using the Bristol Stool Form Scale

    Measured: Up to 12 weeks

  6. Incidence of adverse events as a measure of tolerability

    Measured: Up to 16 weeks

  7. Abnormalities of laboratory tests as a measure of tolerability

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
611 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01100684
Sponsor's protocol ID
ASMP3001
Status last verified
Dec 2013
First submitted
6 Apr 2010
Last updated
18 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asimadoline in people with Diarrhea Predominant Irritable Bowel Syndrome, run by Tioga Pharmaceuticals at 142 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12 Week Abdominal Pain and Stool (APS) Frequency Responder (time frame: Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01100684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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