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Clinical trial: asimadoline in the treatment of patients with irritable bowel syndrome.
Aliment Pharmacol Ther. 2008 Jul; 28(2):239-49.AP

Abstract

BACKGROUND

In models of irritable bowel syndrome (IBS), asimadoline, a kappa-opioid agonist, improves pain and abnormal bowel function.

AIM

To evaluate the effects of three doses of asimadoline and placebo in subjects with IBS through a double-blind, randomized, placebo-controlled trial.

METHODS

Patients were randomly assigned to receive asimadoline 0.15, 0.5, 1.0 mg or placebo BID for 12 weeks. The primary efficacy measure was number of months of adequate relief of IBS pain or discomfort, with a prospective plan to evaluate adequate relief data by entry baseline pain and subtype. Several other endpoints were also evaluated.

RESULTS

Five hundred and ninety-six patients were randomized. In the ITT population, statistically significant improvement on the primary endpoint was not seen. However, in diarrhoea-predominant IBS patients with at least baseline moderate pain, asimadoline (0.5 mg) produced significant improvement on total number of months with adequate relief of IBS pain or discomfort (46.7% vs. 20.0%), adequate relief of IBS symptoms (46.7% vs. 23.0%), pain scores (week 12: -1.6 vs. -0.7), pain free days (42.9% vs. 18.0%), urgency and stool frequency (-2.3 vs. -0.3). In patients with alternating IBS, significant improvement was seen on adequate relief endpoints. Asimadoline was well tolerated.

CONCLUSION

Asimadoline warrants further evaluation as a treatment for IBS.

Authors+Show Affiliations

RTI-Health Solutions, Research Triangle Park, NC, USA. amangel@rti.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18466359

Citation

Mangel, A W., et al. "Clinical Trial: Asimadoline in the Treatment of Patients With Irritable Bowel Syndrome." Alimentary Pharmacology & Therapeutics, vol. 28, no. 2, 2008, pp. 239-49.
Mangel AW, Bornstein JD, Hamm LR, et al. Clinical trial: asimadoline in the treatment of patients with irritable bowel syndrome. Aliment Pharmacol Ther. 2008;28(2):239-49.
Mangel, A. W., Bornstein, J. D., Hamm, L. R., Buda, J., Wang, J., Irish, W., & Urso, D. (2008). Clinical trial: asimadoline in the treatment of patients with irritable bowel syndrome. Alimentary Pharmacology & Therapeutics, 28(2), 239-49. https://doi.org/10.1111/j.1365-2036.2008.03730.x
Mangel AW, et al. Clinical Trial: Asimadoline in the Treatment of Patients With Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2008;28(2):239-49. PubMed PMID: 18466359.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical trial: asimadoline in the treatment of patients with irritable bowel syndrome. AU - Mangel,A W, AU - Bornstein,J D, AU - Hamm,L R, AU - Buda,J, AU - Wang,J, AU - Irish,W, AU - Urso,D, Y1 - 2008/05/07/ PY - 2008/5/10/pubmed PY - 2008/10/14/medline PY - 2008/5/10/entrez SP - 239 EP - 49 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 28 IS - 2 N2 - BACKGROUND: In models of irritable bowel syndrome (IBS), asimadoline, a kappa-opioid agonist, improves pain and abnormal bowel function. AIM: To evaluate the effects of three doses of asimadoline and placebo in subjects with IBS through a double-blind, randomized, placebo-controlled trial. METHODS: Patients were randomly assigned to receive asimadoline 0.15, 0.5, 1.0 mg or placebo BID for 12 weeks. The primary efficacy measure was number of months of adequate relief of IBS pain or discomfort, with a prospective plan to evaluate adequate relief data by entry baseline pain and subtype. Several other endpoints were also evaluated. RESULTS: Five hundred and ninety-six patients were randomized. In the ITT population, statistically significant improvement on the primary endpoint was not seen. However, in diarrhoea-predominant IBS patients with at least baseline moderate pain, asimadoline (0.5 mg) produced significant improvement on total number of months with adequate relief of IBS pain or discomfort (46.7% vs. 20.0%), adequate relief of IBS symptoms (46.7% vs. 23.0%), pain scores (week 12: -1.6 vs. -0.7), pain free days (42.9% vs. 18.0%), urgency and stool frequency (-2.3 vs. -0.3). In patients with alternating IBS, significant improvement was seen on adequate relief endpoints. Asimadoline was well tolerated. CONCLUSION: Asimadoline warrants further evaluation as a treatment for IBS. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/18466359/Clinical_trial:_asimadoline_in_the_treatment_of_patients_with_irritable_bowel_syndrome_ L2 - https://doi.org/10.1111/j.1365-2036.2008.03730.x DB - PRIME DP - Unbound Medicine ER -