Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborator:
RTI Health Solutions
Information provided by (Responsible Party):
Tioga Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00454688
First received: March 29, 2007
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Asimadoline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Further study details as provided by Tioga Pharmaceuticals:

Primary Outcome Measures:
  • Relief of IBS Pain - total months [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.


Secondary Outcome Measures:
  • Relief of IBS Pain - percent of patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with adequate relief of IBS pain or discomfort

  • Relief of IBS Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Adequate relief of IBS symptoms

  • Lower GI function - change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in abdominal pain score

  • Abdominal Discomfort Score - change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in abdominal discomfort score


Enrollment: 596
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Experimental: Asimadoline 0.15 mg Drug: Asimadoline
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
Experimental: Asimadoline 0.5 mg Drug: Asimadoline
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
Experimental: Asimadoline 1.0 mg Drug: Asimadoline
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454688

  Show 112 Study Locations
Sponsors and Collaborators
Tioga Pharmaceuticals
RTI Health Solutions
Investigators
Study Chair: Allen Mangel, MD, PhD Tioga Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tioga Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00454688     History of Changes
Other Study ID Numbers: ASMP2003
Study First Received: March 29, 2007
Last Updated: October 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Tioga Pharmaceuticals:
Irritable Bowel Syndrome
Asimadoline

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014