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

Sponsor
Mansoura University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00915616
Collaborator
(none)
4
Arms

Study Details

Study Description

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
Phase 3

Study Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    42 Years to 56 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00915616
    Other Study ID Numbers:
    • Melatonin and reflux
    First Posted:
    Jun 8, 2009
    Last Update Posted:
    Jun 8, 2009
    Last Verified:
    Jun 1, 2009
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Melatonin

    Study Results

    No Results Posted as of Jun 8, 2009