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)

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00628342

Collaborator

(none)

600

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Esomeprazole Drug: Esomeprazole Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Aug 1, 2003

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Esomeprazole 20mg Oral tablet once daily Other Names: Nexium
Experimental: 2	Drug: Esomeprazole 40mg Oral tablet once daily Other Names: Nexium
Placebo Comparator: 3	Drug: Placebo Oral once daily

Arm

Intervention/Treatment

Experimental: 1

Drug: Esomeprazole

20mg Oral tablet once daily

Other Names:

Nexium

Experimental: 2

Drug: Esomeprazole

40mg Oral tablet once daily

Other Names:

Nexium

Placebo Comparator: 3

Drug: Placebo

Oral once daily

Outcome Measures

Primary Outcome Measures

Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD. [Daily diary cards completed by the patients.]

Secondary Outcome Measures

To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc [Daily diary cards completed by the patients]
To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre [Daily diary cards completed by the patients.]
To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD [Daily diary cards completed by the patients.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.