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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00915616
• Other study ID #: Melatonin and reflux
• Status: Withdrawn
• Phase: Phase 3
• First received: June 1, 2009
• Last updated: June 5, 2009

Study information

• Verified date: June 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Years to 56 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Melatonin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University