NCT01128582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 12, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

May 21, 2010

Last Update Submit

May 11, 2011

Conditions

Gastroesophageal Reflux DiseaseChronic Insomnia

Keywords

GERDInsomniaAcid RefluxHeartburn

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Improving quality of sleep and quality of life.

    4 week trial period

Study Arms (2)

Rozerem

ACTIVE COMPARATOR

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

Drug: Rozerem (ramelteon)

placebo

PLACEBO COMPARATOR

Comparing the effect of Rozerem vs. placebo on GERD symptomatology

Drug: placebo

Interventions

Rozerem (ramelteon)DRUG

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

Also known as: Rozerem, ramelteon
Rozerem
placeboDRUG

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

Also known as: sugar pill
placebo

Eligibility Criteria

AgeUp to 82 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Arizona Veterans Health Care System

Tucson, Arizona, 85723, United States

Location

Related Publications (1)

  • 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.

    PMID: 25887111DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxSleep Initiation and Maintenance DisordersHeartburn

Interventions

ramelteonSugars

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Ronnie Fass, MD

    Southern Arizona Veterans Health Care System-BREFSA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 24, 2010

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 12, 2011

Record last verified: 2011-03

Locations

US(1)