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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)

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

February 26, 2008
March 11, 2009
April 2003
August 2003   (final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT00628342 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
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)
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
  • 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
  • Experimental: 1
    Intervention: Drug: Esomeprazole
  • Experimental: 2
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
August 2003
August 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00628342
D961AC00001
Not Provided
Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
AstraZeneca
March 2009

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