search
Back to results

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

Primary Purpose

Gastroesophageal Reflux Disease, Chronic Insomnia

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rozerem (ramelteon)
placebo
Sponsored by
Southern Arizona VA Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Insomnia, Acid Reflux, Heartburn

Eligibility Criteria

undefined - 82 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern Arizona Veterans Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rozerem

placebo

Arm Description

Comparing the effect of Rozerem vs. placebo on GERD symptomatology.

Comparing the effect of Rozerem vs. placebo on GERD symptomatology

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 21, 2010
Last Updated
May 11, 2011
Sponsor
Southern Arizona VA Health Care System
search

1. Study Identification

Unique Protocol Identification Number
NCT01128582
Brief Title
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Acronym
Rozerem
Official Title
Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southern Arizona VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Chronic Insomnia
Keywords
GERD, Insomnia, Acid Reflux, Heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rozerem
Arm Type
Active Comparator
Arm Description
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Comparing the effect of Rozerem vs. placebo on GERD symptomatology
Intervention Type
Drug
Intervention Name(s)
Rozerem (ramelteon)
Other Intervention Name(s)
Rozerem, ramelteon
Intervention Description
dosage= take 1 tablet(8 MG) 20 min. before bedtime
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
Primary Outcome Measure Information:
Title
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
Description
The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
Time Frame
4 week trial
Secondary Outcome Measure Information:
Title
Improving quality of sleep and quality of life.
Description
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.
Time Frame
4 week trial period

10. Eligibility

Sex
All
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Organizational Affiliation
Southern Arizona Veterans Health Care System-BREFSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona Veterans Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887111
Citation
Jha LK, Fass R, Gadam R, Maradey-Romero C, Nasrollah L, Hershcovici T, Quan SF, Dickman R. The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study. J Clin Gastroenterol. 2016 Feb;50(2):e19-24. doi: 10.1097/MCG.0000000000000322.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs