Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Southern Arizona VA Health Care System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT01128582
First received: May 21, 2010
Last updated: May 11, 2011
Last verified: March 2011

May 21, 2010
May 11, 2011
March 2009
December 2011   (final data collection date for primary outcome measure)
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology. [ Time Frame: 4 week trial ] [ Designated as safety issue: No ]
The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
The effect of Rozerem vs. placebo on GERD symptomatology. [ Time Frame: 4 week trial ] [ Designated as safety issue: No ]
The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
Complete list of historical versions of study NCT01128582 on ClinicalTrials.gov Archive Site
Improving quality of sleep and quality of life. [ Time Frame: 4 week trial period ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Chronic Insomnia
  • Drug: Rozerem (ramelteon)
    dosage= take 1 tablet(8 MG) 20 min. before bedtime
    Other Names:
    • Rozerem
    • ramelteon
  • Drug: placebo
    Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
    Other Names:
    • placebo
    • sugar pill
  • Active Comparator: Rozerem
    Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
    Intervention: Drug: Rozerem (ramelteon)
  • Placebo Comparator: placebo
    Comparing the effect of Rozerem vs. placebo on GERD symptomatology
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
up to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128582
Rozerem
No
Ronnie Fass MD, Southern Arizona VA Health Care System
Southern Arizona VA Health Care System
Not Provided
Principal Investigator: Ronnie Fass, MD Southern Arizona Veterans Health Care System-BREFSA
Southern Arizona VA Health Care System
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP