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

Gastroesophageal Reflux Disease Clinical Trial

— Rozerem  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01128582
• Other study ID #: Rozerem
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 21, 2010
• Last updated: May 11, 2011
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Southern Arizona VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 82 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Rozerem (ramelteon)
dosage= take 1 tablet(8 MG) 20 min. before bedtime
• placebo
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.

Locations

Country	Name	City	State
United States	Southern Arizona Veterans Health Care System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.	The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.	4 week trial	No
Secondary	Improving quality of sleep and quality of life.	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.	4 week trial period	No