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NCT01268709 Clinical Trial

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01268709
Other study ID # YRC-1246
Secondary ID
Status Completed
Phase Phase 2
First received December 30, 2010
Last updated December 30, 2010

Study information
Verified date December 2010
Source Qom University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health and Medical Education
Study type Interventional

Clinical Trial Summary

The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria

Exclusion Criteria:

- Gastrointestinal bleeding

- More than 5% weight loss in the last 6 months

- Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Doxepin

• Nortriptyline

• placebo

Locations
Country Name City State
Iran, Islamic Republic of Gastrointestinal Research center,Beheshti Hospital Qom

Sponsors (2)
Lead Sponsor Collaborator
Qom University of Medical Sciences Young Researchers Club

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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