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Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268709
First Posted: December 31, 2010
Last Update Posted: December 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Young Researchers Club
Information provided by:
Qom University of Medical Sciences
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01268709     History of Changes
Other Study ID Numbers: YRC-1246
First Submitted: December 30, 2010
First Posted: December 31, 2010
Last Update Posted: December 31, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nortriptyline
Doxepin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Histamine Antagonists
Histamine Agents