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Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborator:
Young Researchers Club
Information provided by:
Qom University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01268709
First received: December 30, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: Doxepin
Drug: Nortriptyline
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Qom University of Medical Sciences:

Arms Assigned Interventions
Active Comparator: doxepin Drug: Doxepin
Active Comparator: nortriptyline Drug: Nortriptyline
Placebo Comparator: placebo Drug: placebo

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268709

Locations
Iran, Islamic Republic of
Gastrointestinal Research center,Beheshti Hospital
Qom, Iran, Islamic Republic of, 1677859642
Sponsors and Collaborators
Qom University of Medical Sciences
Young Researchers Club
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01268709     History of Changes
Other Study ID Numbers: YRC-1246
Study First Received: December 30, 2010
Last Updated: December 30, 2010
Health Authority: Iran: Ministry of Health and Medical Education

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Doxepin
Nortriptyline
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013