View Clinical Trial (Medical Research Study)

Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia. - NCT01128582-85723(Clinical Trial 650932)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Tucson
State:  
AZ
Zip Code: 85723
Conditions: Gastroesophageal Reflux Disease - Chronic Insomnia
Purpose: 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.
Study summary: 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.
Criteria: Inclusion Criteria: - 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 Exclusion Criteria: - 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.
Study is available at: Southern Arizona Veterans Health Care System
Tucson, AZ 85723
United States

Primary Contact:
Ronnnie Fass, MD
Email: ronnie.fass@va.gov
Phone: 520-792-1450

Secondary Contact:
Ronnie FASS, MD
Email: ronnie.fass@va.gov
Phone: 520-792-1450
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.