Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Qom University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Nortriptyline; Drug: Doxepin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01268709

YRC-1246

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups, including a placebo group

doxepin

Active Comparator group

Treatment:

Drug: Doxepin

nortriptyline

Active Comparator group

Treatment:

Drug: Nortriptyline

placebo

Placebo Comparator group

Treatment:

Drug: placebo