Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
This trial is active, not recruiting.
|Conditions||gastroesophageal reflux disease, chronic insomnia|
|Treatments||rozerem (ramelteon), placebo|
|Sponsor||Southern Arizona VA Health Care System|
|Start date||March 2009|
|End date||December 2011|
|Trial size||40 participants|
|Trial identifier||NCT01128582, Rozerem|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
time frame: 4 week trial
Improving quality of sleep and quality of life.
time frame: 4 week trial period
Male or female participants up to 82 years old.
- Stop H2 blockers 72 hrs prior to starting study
- Stop PPI - 3 weeks prior to staring study
- Heartburn 3+ times a week
- Insomnia 3+ times a week for 3 months
- Erosive esophagitis or Abnormal pH test
- On PPI or H2 blocker & not willing to get off
- Normal EGD (upper endoscopy) w/ normal pH test
- Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C&D) LA=Los Angeles criteria. Grades include A-D
- Previous gastrointestinal Surgery
- HX of Diabetes/neuropathy
- HX of seizures
- Known psychological abnormalities(depression,anxiety...)
- Clinically Significant Underlying co morbidity
- Narcotic medications(pain meds)
- Regularly taking sleeping medications (2 week wash-out allowed)
- Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.
|Official title||Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.|
|Principal investigator||Ronnie Fass, MD|
|Description||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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