Trial | NCT00454688  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    asimadoline ...

  • Study Participants

    596
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.
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 Started
Aug 31
2006
Primary Completion
Nov 30
2007
Study Completion
Dec 31
2007
Last Update
Oct 18
2011
Estimate

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

Drug Placebo

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

Placebo Placebo Comparator

Asimadoline 0.15 mg Experimental

Asimadoline 0.5 mg Experimental

Asimadoline 1.0 mg Experimental

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
No Results Posted