Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2008-10-31
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Melatonin treatment group
Melatonin
4 mg of Melatonin once a day for 3 months
B
Omeprazole 20 mg once a day for 3 months
omeprazole
omeprazole 20 mg once a day
C
Placebo once a day for 3 months
Placebo
Placebo once a day
Interventions
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Melatonin
4 mg of Melatonin once a day for 3 months
omeprazole
omeprazole 20 mg once a day
Placebo
Placebo once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Principal Investigators
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Ram M Dickman, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Countries
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Central Contacts
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References
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Pereira Rde S. Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole. J Pineal Res. 2006 Oct;41(3):195-200. doi: 10.1111/j.1600-079X.2006.00359.x.
Other Identifiers
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004548
Identifier Type: -
Identifier Source: org_study_id