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To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.
This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozerem | Active Comparator | Comparing the effect of Rozerem vs. placebo on GERD symptomatology. |
|
| placebo | Placebo Comparator | Comparing the effect of Rozerem vs. placebo on GERD symptomatology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozerem (ramelteon) | Drug | dosage= take 1 tablet(8 MG) 20 min. before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology. | The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes. | 4 week trial |
| Measure | Description | Time Frame |
|---|---|---|
| Improving quality of sleep and quality of life. | It is believed that poor quality of sleep can cause more esophageal acid exposure. Thus, it is possible that treatment of insomnia may have a beneficial effect on GERD symptomatology as well as actually reduce esophageal acid reflux. | 4 week trial period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Fass, MD | Southern Arizona Veterans Health Care System-BREFSA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona Veterans Health Care System | Tucson | Arizona | 85723 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25887111 | Derived | Jha LK, Fass R, Gadam R, Maradey-Romero C, Nasrollah L, Hershcovici T, Quan SF, Dickman R. The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study. J Clin Gastroenterol. 2016 Feb;50(2):e19-24. doi: 10.1097/MCG.0000000000000322. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| placebo | Drug | Comparing the effect of Rozerem vs. placebo on GERD symptomatology. |
|
|
| D004066 | Digestive System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |