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The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

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. Identifier: NCT00915616
Recruitment Status : Withdrawn
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Information provided by:
Mansoura University

Brief Summary:
Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Melatonin Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Melatonin

Arm Intervention/treatment
No Intervention: control
9 healthy normal subjects.
Active Comparator: Group II
Included 9 patients suffering from GERD; receiving melatonin alone for treatment of GERD in a dose of 3 mg once daily at the bed time.
Drug: Melatonin
No Intervention: Group III, combined group
Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.
Active Comparator: Group IV
Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
Drug: Melatonin

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patient with GERD ranged from 42 to 56 years

Exclusion Criteria:

  • patients with cardiac disease
  • patients with renal affection
  • patients with liver diseases (due to drug induced, autoimmune disease and viral hepatitis)
  • patients on the drugs known to affect the GIT motility (phenothiazines, anticholinergics, nitrates or calcium channel blockers) were excluded during the time of conduction of the study or the preceding two weeks
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00915616    
Other Study ID Numbers: Melatonin and reflux
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: June 8, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants