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Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Doxepin

Nortriptyline

placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

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

Sites / Locations

Gastrointestinal Research center,Beheshti Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

doxepin

nortriptyline

placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01268709

First Posted

December 30, 2010

Last Updated

December 30, 2010

Sponsor

Qom University of Medical Sciences

Collaborators

Young Researchers Club

1. Study Identification

Unique Protocol Identification Number

NCT01268709

Brief Title

Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Qom University of Medical Sciences

Collaborators

Young Researchers Club

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Arm Title

doxepin

Arm Type

Active Comparator

Arm Title

nortriptyline

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Doxepin

Intervention Type

Drug

Intervention Name(s)

Nortriptyline

Intervention Type

Drug

Intervention Name(s)

placebo

10. Eligibility

Sex

All

Eligibility Criteria

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

Facility Information:

Facility Name

Gastrointestinal Research center,Beheshti Hospital

City

Qom

ZIP/Postal Code

1677859642

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

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