Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

NCT01268709 | Completed Phase 2 DMC

• 1 other identifier: YRC-1246
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Study Arms (3)

doxepin

ACTIVE COMPARATOR

Drug: Doxepin

nortriptyline

ACTIVE COMPARATOR

Drug: Nortriptyline

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Doxepin DRUG

doxepin

Nortriptyline DRUG

nortriptyline

placebo DRUG

placebo

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qom University of Medical Sciences: lead
• Young Researchers Club: collaborator

Study Sites (1)

Gastrointestinal Research center,Beheshti Hospital

Qom, Qom Province, 1677859642, Iran

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Doxepin; Nortriptyline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Oxepins; Ethers, Cyclic; Ethers; Organic Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Last Updated: December 31, 2010

Record last verified: 2010-12

Locations

IR (1)