Effect of Asimadoline, a Member of a New Medication Class, on Acute Attacks of Pain in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): asimadoline
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment