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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)

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ClinicalTrials.gov Identifier: NCT00628342
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
AstraZeneca

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: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]
  3. 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. ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628342


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00628342     History of Changes
Other Study ID Numbers: D961AC00001
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Gastroesophageal Reflux Disease
GERD
Esomeprazole
Heartburn
Nexium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyssomnias
Sleep Wake Disorders
Parasomnias
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action