Effect of Asimadoline, a Member of a New Medication Class, on Acute Attacks of Pain in Irritable Bowel Syndrome

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT00955994
• Lead Sponsor: Mayo Clinic

Brief Summary

The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is a placebo controlled study of the on demand treatment of pain experienced over a 4 week period in patients with irritable bowel syndrome. Patients will record the severity of pain when they take the study medication and two hours later.

Detailed Description

Background:

Asimadoline reduces visceral sensitivity in experimental animal models and has been tested for its effects on gastric sensorimotor function in healthy individuals. It reduces pain sensation in response to distensions that correspond to pressures frequently encountered in the human colon. However, the effects on improvement of pain and gastrointestinal symptoms in individuals with irritable bowel syndrome (IBS) are unclear.

Hypothesis:

The kappa opioid agonist, Asimadoline, reduces pain and discomfort and decreases gastrointestinal symptoms in participants with IBS.

Aim The aim is to compare the effects of Asimadoline (0.5 mg p.r.n, up to 1mg q.i.d.) and placebo on pain and discomfort and other gastrointestinal symptoms in patients with IBS.

Methods:

This is a phase IIB, single center, randomised, double-blind, placebo controlled study of the treatment of pain and discomfort associated with IBS in which study medication or placebo will be administered as required for the relief of these symptoms up to 2 tablets, 4 times per day. After a 2-week run-in period to characterize the nature, frequency and severity of pain to ensure eligibility for the study, participants will treat these pain episodes as the need arises but with strict recommendations on how to self-administer the medication (number, time interval etc?) over a period of 4 weeks. No other pain medications will be permitted during these first 6 weeks (2 weeks run-in, 4 weeks of randomized treatment). During the study, patients will collect daily data which will characterize their pain and other symptoms of IBS, and adequate relief of pain/discomfort. The participants will also keep track of their symptoms and any medications used during a two week observation period after the last dose of medication. A blood sample will be taken and DNA extracted to assess whether IBS patients have single nucleotide polymorphisms in the gene for the kappa receptor.

Anticipated Results and Future Directions:

We anticipate demonstrating that exacerbations of pain in IBS can be effectively reduced by intermittent treatment with the medication, asimadoline. This study will provide preliminary data that will then be used to estimate the sample size required for a phase III program of trials in several centers.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of abdominal pain 2 hours after treatment of pain
Average pain reduction within 2 hours after first dose each day ( pain intensity on VAS before and two hours after the first dose on each day with at least moderate pain)
The primary efficacy analysis includes all days with complete data sets for VAS before and two hours after intake of study medication and a before-treatment pain intensity of at least 30 mm on the VAS
For each of these days the pain reduction of the first dose will be calculated: PID (pain intensity difference) = Pain2h ? Pain0h
The average pain reduction on all these days will be calculated by: first, summing up all PID over the treatment period and second, dividing this result by the number of days with pain

Secondary Outcome Measures

Name	Time	Method
Ease of passage
Adequate relief of IBS pain and
Maximum pain during each day
Frequency of bowel movements (number)
Consistency of bowel movements (Bristol stool scale)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States