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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diarrhea Predominant Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT01100684

Run by

Tioga Pharmaceuticals

People needed

611

Starts

2010-05-01

Expected to finish

2013-06-01

Last updated by the study team

2013-12-18

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• Alliance Clinical Research — Birmingham, Alabama, United States
• Medical Affliated Research Center, Inc. — Huntsville, Alabama, United States
• Saadat Ansari MD LLC — Huntsville, Alabama, United States
• Connect Clinical Research Center — Chandler, Arizona, United States
• Digestive Health Research Unit — Scottsdale, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• ACRC/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• W/C Clinical Research — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Providence Clinical Research — Burbank, California, United States
• GW Research Inc, — Chula Vista, California, United States
• La Jolla Clinical Research, Inc — Chula Vista, California, United States
• Discovery Clinical Research — Encinitas, California, United States
• Digestive & Liver Disease Specialist — Garden Grove, California, United States
• Collaborative Neuroscience Network Inc — Long Beach, California, United States
• California Gastroenterology Associates — Madera, California, United States
• Community Clinical Trials — Orange, California, United States
• Sutter Medical Group Gastroenterology — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• North Alabama Research Center, LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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