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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

42 Years - 56 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Active Comparator

    No Intervention

    Active Comparator

    Arm Label

    control

    Group II

    Group III, combined group

    Group IV

    Arm Description

    9 healthy normal subjects.

    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.

    Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.

    Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2009
    Last Updated
    June 5, 2009
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00915616
    Brief Title
    The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
    Official Title
    The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mansoura University

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    9 healthy normal subjects.
    Arm Title
    Group II
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group III, combined group
    Arm Type
    No Intervention
    Arm Description
    Included 9 patients suffering from GERD; receiving omeprazole alone for treatment of GERD in a dose of 20 mg twice daily.
    Arm Title
    Group IV
    Arm Type
    Active Comparator
    Arm Description
    Included 9 patients suffering from GERD receiving omeprazole and melatonin for treatment of GERD in the same dose of each of them.
    Intervention Type
    Drug
    Intervention Name(s)
    Melatonin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    42 Years
    Maximum Age & Unit of Time
    56 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20082715
    Citation
    Kandil TS, Mousa AA, El-Gendy AA, Abbas AM. The potential therapeutic effect of melatonin in Gastro-Esophageal Reflux Disease. BMC Gastroenterol. 2010 Jan 18;10:7. doi: 10.1186/1471-230X-10-7.
    Results Reference
    derived

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

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