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This study has been withdrawn prior to enrollment.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

June 1, 2009
June 5, 2009
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Complete list of historical versions of study NCT00915616 on ClinicalTrials.gov Archive Site
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The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

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.

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Interventional
Phase 3
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
Drug: Melatonin
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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
Both
42 Years to 56 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00915616
Melatonin and reflux
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Mansoura University
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Mansoura University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP