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

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

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: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.