Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: es...
Eligibility Criteria
Inclusion
- A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
- Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
- Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..
Exclusion
- Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
- Shift workers who work between 12am (midnight) and 6am.
- Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
- Other diseases / conditions as listed in the protocol.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2003
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00628342
Start Date
April 1 2003
End Date
August 1 2003
Last Update
March 12 2009
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