|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01128582 |
|
Date of registration:
|
21/05/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Rozerem |
|
Scientific title:
|
Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia. |
|
Date of first enrolment:
|
March 2009 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01128582 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Ronnie Fass, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Southern Arizona Veterans Health Care System-BREFSA |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
82 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Insomnia
|
|
Gastroesophageal Reflux Disease
|
|
Intervention(s)
|
|
Drug: placebo
|
|
Drug: Rozerem (ramelteon)
|
|
Primary Outcome(s)
|
|
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
[Time Frame: 4 week trial]
|
|
Secondary Outcome(s)
|
|
Improving quality of sleep and quality of life.
[Time Frame: 4 week trial period]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|