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

Last updated: May 11, 2011
Sponsor: Southern Arizona VA Health Care System
Overall Status: Trial Status Unknown

Phase

3

Condition

Insomnia

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT01128582
Rozerem
  • Ages < 82
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 andBenzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.

Study Design

Total Participants: 40
Study Start date:
March 01, 2009
Estimated Completion Date:
December 31, 2011

Study 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.

Connect with a study center

  • Southern Arizona Veterans Health Care System

    Tucson, Arizona 85723
    United States

    Site Not Available

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