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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
History of Changes
  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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Chronic Insomnia
 Drug: Rozerem (ramelteon)
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.

Resource links provided by NLM:

MedlinePlus related topics: GERD
Drug Information available for: Ramelteon
U.S. FDA Resources

Further study details as provided by Southern Arizona VA Health Care System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rozerem
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
 Drug: Rozerem (ramelteon)
dosage= take 1 tablet(8 MG) 20 min. before bedtime
Other Names:
  • Rozerem
  • ramelteon
Placebo Comparator: placebo
Comparing the effect of Rozerem vs. placebo on GERD symptomatology
 Drug: placebo
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
Other Names:
  • placebo
  • sugar pill

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128582

Locations
United States, Arizona
Southern Arizona Veterans Health Care System
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Ronnie Fass, MD Southern Arizona Veterans Health Care System-BREFSA
  More Information

No publications provided

Responsible Party: Ronnie Fass MD, Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT01128582     History of Changes
Other Study ID Numbers: Rozerem
Study First Received: May 21, 2010
Last Updated: May 11, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Southern Arizona VA Health Care System:
GERD
Insomnia
Acid Reflux
Heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sleep Initiation and Maintenance Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013