- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915616
The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease
June 5, 2009 updated by: Mansoura University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
42 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / 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.
|
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
June 1, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 8, 2009
Study Record Updates
Last Update Posted (Estimate)
June 8, 2009
Last Update Submitted That Met QC Criteria
June 5, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastroesophageal Reflux
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- Melatonin and reflux
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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