Gastroesophageal Reflux DiseasePhase 3RozeremNCT01128582
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
A Phase 3 study testing Rozerem (ramelteon) in people with Gastroesophageal Reflux Disease and Chronic Insomnia, run by Southern Arizona VA Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 82 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Chronic Insomnia
- What is being tested?
- Rozerem (ramelteon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona Veterans Health Care System
Tucson, Arizona, 85723
About this study
Official title: Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease, Chronic Insomnia
- Being tested
- Rozerem (ramelteon), placebo
- Keywords
- GERD, Insomnia, Acid Reflux, Heartburn
- Medical subject headings
- Gastroesophageal Reflux, Sleep Initiation and Maintenance Disorders, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rozerem (ramelteon)Drug
Also called Rozerem, ramelteon
dosage= take 1 tablet(8 MG) 20 min. before bedtime
placeboDrug
Also called sugar pill
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
| Study group | Role | What they receive |
|---|---|---|
| Rozerem | Active comparator | Comparing the effect of Rozerem vs. placebo on GERD symptomatology. Receives: Drug: Rozerem (ramelteon) |
| placebo | Placebo comparator | Comparing the effect of Rozerem vs. placebo on GERD symptomatology Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week trial
Secondary outcomes (1)
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.
Measured: 4 week trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Arizona VA Health Care System
- Sponsor type
- US federal agency
- Investigators
- Ronnie Fass, MD, Principal investigator, Southern Arizona Veterans Health Care System-BREFSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128582
- Sponsor's protocol ID
- Rozerem
- Acronym
- Rozerem
- Status last verified
- Mar 2011
- First submitted
- 21 May 2010
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25887111
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
- ClinicalTrials.gov ID
- NCT01128582
- Acronym / sponsor ID
- Rozerem / Rozerem
- Conditions
- Gastroesophageal Reflux Disease, Chronic Insomnia
- Keywords
- GERD, Insomnia, Acid Reflux, Heartburn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern Arizona VA Health Care SystemUS federal agency
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rozerem | Active comparator | Drug: Rozerem (ramelteon)Comparing the effect of Rozerem vs. placebo on GERD symptomatology. |
| placebo | Placebo comparator | Drug: placeboComparing the effect of Rozerem vs. placebo on GERD symptomatology |
Who may qualify
- Ages
- Up to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rozerem (ramelteon)Also: Rozerem, ramelteondosage= take 1 tablet(8 MG) 20 min. before bedtime | Drug | Rozerem |
| placeboAlso: sugar pillComparing the effect of Rozerem vs. placebo on GERD symptomatology. | Drug | placebo |
Primary outcome
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
Time frame: 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.
1 secondary outcome
Improving quality of sleep and quality of life.
Time frame: 4 week trial period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Derived from this study: PubMed 25887111Jha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Fass, MD principal investigator
Southern Arizona Veterans Health Care System-BREFSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rozerem (ramelteon) in people with Gastroesophageal Reflux Disease and Chronic Insomnia, run by Southern Arizona VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology. (time frame: 4 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.