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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
Drug: Melatonin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   42 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00915616     History of Changes
Other Study ID Numbers: Melatonin and reflux
Study First Received: June 1, 2009
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014