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Completed

NCT Number: NCT00454688

Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Affiliated Research Center, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asimadoline

Drug

Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks

Other names: EMD 61753, EMR 63320

Placebo

Drug

Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Primary outcomes

  1. Relief of IBS Pain - total months

    Time frame: 12 weeks

    The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.

Secondary outcomes

  1. Relief of IBS Pain - percent of patients

    Time frame: 12 weeks

    Proportion of subjects with adequate relief of IBS pain or discomfort

  2. Relief of IBS Symptoms

    Time frame: 12 weeks

    Adequate relief of IBS symptoms

  3. Lower GI function - change from baseline

    Time frame: 12 weeks

    Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)

  4. Abdominal Pain Score - change from baseline

    Time frame: 12 weeks

    Change from baseline in abdominal pain score

  5. Abdominal Discomfort Score - change from baseline

    Time frame: 12 weeks

    Change from baseline in abdominal discomfort score

Sponsors and collaborators

Lead sponsor

Tioga Pharmaceuticals

Industry

Collaborators

  • RTI Health Solutions

Registry information

Official study title

A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 2, 2007
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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