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Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

NCT ID: NCT01268709

Last Updated: 2010-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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doxepin

Group Type ACTIVE_COMPARATOR

Doxepin

Intervention Type DRUG

nortriptyline

Group Type ACTIVE_COMPARATOR

Nortriptyline

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Doxepin

Intervention Type DRUG

Nortriptyline

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Young Researchers Club

UNKNOWN

Sponsor Role collaborator

Qom University of Medical Sciences

OTHER

Sponsor Role lead

Locations

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Gastrointestinal Research center,Beheshti Hospital

Qom, Qom Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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YRC-1246

Identifier Type: -

Identifier Source: org_study_id