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SThe Effects of Melatonin on GERD Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00564590
First received: November 26, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: Melatonin
Other: omeprazole
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Melatonin on GERD Symptoms and Esophageal Acid Exposure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • This study will test the efficacy of melatonin (10 mg once a day) as compared to standard dose PPI (omeprazole 20 mg once a day) and placebo on different subjective and objective parameters of 150 patients with GERD. [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • To determine the effect of melatonin versus standard-dose PPI versus placebo on frequency and duration of TLESRs. [ Time Frame: 3 years ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: January 2011
Arms Assigned Interventions
Experimental: A
Melatonin treatment group
 Drug: Melatonin
4 mg of Melatonin once a day for 3 months
Active Comparator: B
Omeprazole 20 mg once a day for 3 months
 Other: omeprazole
omeprazole 20 mg once a day
Other Name: Omepradex
Experimental: C
Placebo once a day for 3 months
 Drug: Placebo
Placebo once a day
Other Name: Placebo

Detailed Description:

Background: Gastroesophageal reflux disease (GERD) is a chronic, persistent and common medical problem. The standard of care for GERD includes chronic administration of acid-suppressive drugs. However, clinical failure in GERD is increasingly reported.

Aim: To determine the efficacy of treatment with melatonin as compared to standard dose proton pump inhibitor (PPI) as compared to placebo in patients with GERD.

Study objectives: [1] To compare the degree of GERD symptoms improvement and esophageal acid sensitivity before and after treatment. [2] To determine the effect of treatment on the % total, upright and supine time pH <4 using 24-hour esophageal pH monitoring. [3] To determine the effect of treatment on frequency and duration of lower esophageal sphincter relaxation. [4] To compare the quality of life and quality of sleep in GERD patients before and after treatment.

Methods: This is a randomized, double blind, parallel groups study of 150 patients with GERD. Patients with classic heartburn symptoms (heartburn and/or regurgitation) and normal upper endoscopy from the gastroenterology department at Rabin Medical Center will be enrolled into the study. At baseline, all enrolled patients will have 24-hour esophageal pH monitoring and a modified acid perfusion test to assess the extent of distal esophageal acid exposure and esophageal acid sensitivity, respectively. Patients will be evaluated by a demographics questionnaire, the GERD Symptom Questionnaire, the Quality of Sleep questionnaire and the SF-36. Baseline urinary excretion of the main melatonin metabolite, 6-sulfatoxymelatonin (6SMT) will be assessed in all subjects at baseline. Patients will be randomized to either melatonin or standard dose PPI or placebo over a period of 4 weeks. In addition patients will fill a diary on a daily basis that documents severity and frequency of GERD-related symptoms. Symptom score (frequency x severity) will be calculated for previous 7 days at baseline and at the end of treatment in all groups. After 4 weeks of treatment, patients will undergo a second 24-hour esophageal pH monitoring, a modified acid perfusion test and will complete the GERD Symptom Questionnaire, the Quality of Sleep Questionnaire and the SF-36.

Implications: This study will determine if melatonin decreases GERD symptoms, acid esophageal exposure and improves quality of life and sleep in patients with GERD. Furthermore, if there will be a significant clinical response to melatonin it will be possible to add this compound to the treatment armamentum of GERD.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564590

Contacts
Contact: Ram M Dickman, MD 03:9377236 dickmanr@clalit.org.il
Contact: Tami Lederfine 03:9377040 Tamila@clalit.org.il

Locations
Israel
Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel, 49100
Principal Investigator: Ram M Dickman, MD            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ram M Dickman, MD Rabin Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00564590     History of Changes
Other Study ID Numbers: 004548
Study First Received: November 26, 2007
Last Updated: November 26, 2007
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013