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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Southern Arizona VA Health Care System.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128582
First Posted: May 24, 2010
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southern Arizona VA Health Care System
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]
    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 ]
    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 Name: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 82 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronnie Fass MD, Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier: NCT01128582     History of Changes
Other Study ID Numbers: Rozerem
First Submitted: May 21, 2010
First Posted: May 24, 2010
Last Update Posted: May 12, 2011
Last Verified: March 2011

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

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