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)

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Gastroesophageal Reflux Disease (GERD)

Treatments

Drug: Placebo

Drug: Esomeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00628342

D961AC00001

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.