SThe Effects of Melatonin on GERD Symptoms

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Melatonin; Omeprazole

Criteria

INCLUSION CRITERIA:

• Ages 18-75.

• Male or female.

• GERD symptoms at least twice a week for the last three months.

• Able to read, understand and complete study questionnaires and diary

• Understand the study procedures and sign written informed consent.

• Able to comply with all study requirements.

EXCLUSION CRITERIA:

• Subjects with erosive esophagitis (EE), Barrett's esophagus (BE) and esophageal stricture or adenocarcinoma on upper endoscopy.

• Subjects with previous upper gastrointestinal surgery.

• Subjects with clinically significant medical conditions (cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic and psychiatric); examples as follows: liver cirrhosis, severe COPD, severe renal failure, severe heart failure, active malignancy.

• Subjects requiring narcotics (morphine, methadone, etc.).

• Subjects requiring melatonin

• Subjects with diabetes, scleroderma and neuromuscular disorders.

• Lactating or pregnant women.

• Subjects with an unrecognized lifestyle such as shift workers.