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)

NCT ID: NCT00628342

Last Updated: 2009-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2003-08-31

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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

20mg Oral tablet once daily

2

Group Type: EXPERIMENTAL

Esomeprazole

Intervention Type: DRUG

40mg Oral tablet once daily

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral once daily

Interventions

Esomeprazole

20mg Oral tablet once daily

Intervention Type: DRUG

Esomeprazole

40mg Oral tablet once daily

Intervention Type: DRUG

Placebo

Oral once daily

Intervention Type: DRUG

Other Intervention Names

Nexium; Nexium

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

Paula Fernstrom

Role: STUDY_DIRECTOR

Nexium Global Product Director, AstraZeneca

References

Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.

Reference Type: DERIVED

PMID: 25478944 (View on PubMed)

Other Identifiers

D961AC00001

Identifier Type: -

Identifier Source: org_study_id