SThe Effects of Melatonin on GERD Symptoms
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|ClinicalTrials.gov Identifier: NCT00564590|
Recruitment Status : Unknown
Verified November 2007 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 28, 2007
Last Update Posted : November 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Melatonin Other: omeprazole Drug: Placebo||Phase 1 Phase 2|
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:  To compare the degree of GERD symptoms improvement and esophageal acid sensitivity before and after treatment.  To determine the effect of treatment on the % total, upright and supine time pH <4 using 24-hour esophageal pH monitoring.  To determine the effect of treatment on frequency and duration of lower esophageal sphincter relaxation.  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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Melatonin on GERD Symptoms and Esophageal Acid Exposure|
|Study Start Date :||October 2008|
|Estimated Study Completion Date :||January 2011|
Melatonin treatment group
4 mg of Melatonin once a day for 3 months
Active Comparator: B
Omeprazole 20 mg once a day for 3 months
omeprazole 20 mg once a day
Other Name: Omepradex
Placebo once a day for 3 months
Placebo once a day
- 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 ]
- To determine the effect of melatonin versus standard-dose PPI versus placebo on frequency and duration of TLESRs. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564590
|Contact: Ram M Dickman, MD||03:firstname.lastname@example.org|
|Contact: Tami Lederfine||03:9377040||Tamila@clalit.org.il|
|Rabin Medical Center, Beilinson Hospital|
|Petach Tikva, Israel, 49100|
|Principal Investigator: Ram M Dickman, MD|
|Principal Investigator:||Ram M Dickman, MD||Rabin Medical Center|