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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01128582

Acronym

Rozerem

Enrollment

Registered

2010-05-24

Start date

2009-03-31

Completion date

2011-12-31

Last updated

2011-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insomnia, Gastroesophageal Reflux Disease

Keywords

GERD, Insomnia, Acid Reflux, Heartburn

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.

Interventions

DRUGRozerem (ramelteon)

dosage= take 1 tablet(8 MG) 20 min. before bedtime

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 82 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.	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

Measure	Time frame	Description
Improving quality of sleep and quality of life.	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026