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)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00628342

First received: February 26, 2008

Last updated: March 11, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2008

Last Updated Date

March 11, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Daily diary cards completed by the patients. ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00628342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Daily diary cards completed by the patients. ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

Drug: Esomeprazole
20mg Oral tablet once daily

Other Name: Nexium
Drug: Esomeprazole
40mg Oral tablet once daily

Other Name: Nexium
Drug: Placebo
Oral once daily

Study Arm (s)

Experimental: 1
Intervention: Drug: Esomeprazole
Experimental: 2
Intervention: Drug: Esomeprazole
Placebo Comparator: 3
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

600

Completion Date

August 2003

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00628342

Other Study ID Numbers ^ICMJE

D961AC00001

Has Data Monitoring Committee

Not Provided

Responsible Party

Tore Lind, MD - Nexium Medical Science Director, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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