Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Key facts

Study ID

NCT00454688

Run by

Tioga Pharmaceuticals

People needed

596

Starts

2006-08-01

Expected to finish

2007-12-01

Last updated by the study team

2011-10-18

Who can join

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

You may qualify if…

• Males and females aged 18-79
• Must sign an ICF
• Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
• Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
• Must demonstrate a willingness to comply with daily telephone diary entry

You may not qualify if…

• Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
• Pregnant or breastfeeding females
• Refusal to discontinue prohibited concomitant medications
• Use of an investigational drug or participation in an investigational study within 30 days of screening
• Inability or unwillingness to use the touch-tone telephone data entry system

Where it is running

• Lovelace Scientific Resources — Pheonix, Arizona, United States
• Lovelace Scientific Resources — Phoenix, Arizona, United States
• Redpoint Research — Phoenix, Arizona, United States
• Mayo Clinic Scottsdale - Division of Gastroenterology — Scottsdale, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Sutter Institute for Medical Research — Elk Grove, California, United States
• Digestive & Liver Disease Specialists — Garden Grove, California, United States
• Irvine Center for Clinical Research Inc. — Irvine, California, United States
• Community Clinical Trials — Orange, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Nothern California Research — Sacramento, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• Western States Clinical Research Inc — Wheat Ridge, Colorado, United States
• Clinical Research Consultants, LLC — Stratford, Connecticut, United States
• Phoenix Internal Medicine Associates, LLC — Waterbury, Connecticut, United States
• Meridian Research — Brooksville, Florida, United States
• Florida Medical Research Institute — Gainesville, Florida, United States
• Research Consultants Group — Hialeah, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Universal Clinical Research & Technology — Orlando, Florida, United States
• Penninsula Research, Inc — Ormond Beach, Florida, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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