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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Mansoura University

ClinicalTrials.gov Identifier:

NCT00915616

First received: June 1, 2009

Last updated: June 5, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 1, 2009
Last Updated Date	June 5, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00915616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
Official Title ^ICMJE	The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Gastroesophageal Reflux Disease
Intervention ^ICMJE	Drug: Melatonin
Study Arm (s)	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. Intervention: 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. Intervention: Drug: Melatonin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	42 Years to 56 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00915616
Other Study ID Numbers ^ICMJE	Melatonin and reflux
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Mansoura University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mansoura University
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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