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
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Esomeprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ Time Frame: 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 [ 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. ]

Estimated Enrollment: 600
Study Start Date: April 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628342

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

No publications provided

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00628342     History of Changes
Other Study ID Numbers: D961AC00001
Study First Received: February 26, 2008
Last Updated: March 11, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014