Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Asimadoline

• Registration Number: NCT00454688
• Lead Sponsor: Tioga Pharmaceuticals

Brief Summary

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.

Detailed Description

A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-29
• Study First Posted: 2007-04-02
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Asimadoline 0.15 mg	Asimadoline	-
Asimadoline 0.5 mg	Asimadoline	-
Asimadoline 1.0 mg	Asimadoline	-

Primary Outcome Measures

Name	Time	Method
Relief of IBS Pain - total months	12 weeks	The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.

Secondary Outcome Measures

Name	Time	Method
Relief of IBS Pain - percent of patients	12 weeks	Proportion of subjects with adequate relief of IBS pain or discomfort
Relief of IBS Symptoms	12 weeks	Adequate relief of IBS symptoms
Lower GI function - change from baseline	12 weeks	Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Abdominal Pain Score - change from baseline	12 weeks	Change from baseline in abdominal pain score
Abdominal Discomfort Score - change from baseline	12 weeks	Change from baseline in abdominal discomfort score

Trial Locations

Locations (106)

Medical Affiliated Research Center; 🇺🇸 Huntsville, Alabama, United States

Lovelace Scientific Resources; 🇺🇸 Sarasota, Florida, 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; 🇺🇸 Sacramento, 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

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