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SThe Effects of Melatonin on GERD Symptoms

NCT00564590 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-11-28

No results posted yet for this study

Summary

We hypothesize that melatonin as compared to PPI and to placebo, improves GERD symptoms by decreasing esophageal acid exposure and esophageal acid sensitivity in GERD. We hypothesize that melatonin as compared to PPI and to placebo reduce the frequency and duration of transient lower esophageal sphincter relaxations (TLESRs). In addition we hypothesize that melatonin as compared to PPI and to placebo improves quality of life and quality of sleep of GERD patients.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Melatonin

4 mg of Melatonin once a day for 3 months

OTHER

omeprazole

omeprazole 20 mg once a day

DRUG

Placebo

Placebo once a day

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Ram M Dickman, MD · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Completion
2011-01-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564590 on ClinicalTrials.gov