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

NCT00915616 | Withdrawn Phase 3

• 1 other identifier: Melatonin and reflux
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux Disease

Study Arms (4)

control

NO INTERVENTION

9 healthy normal subjects.

Group II

ACTIVE COMPARATOR

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

Group III, combined group

NO INTERVENTION

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

Group IV

ACTIVE COMPARATOR

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

Drug: Melatonin

Interventions

Melatonin DRUG

Group II; Group IV

Eligibility Criteria

• Age: 42 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patient with GERD ranged from 42 to 56 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• 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.

  PMID: 20082715 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 8, 2009
• Last Updated: June 8, 2009

Record last verified: 2009-06