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Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660660
First received: April 15, 2008
Last updated: March 10, 2009
Last verified: March 2009

April 15, 2008
March 10, 2009
April 2008
July 2008   (final data collection date for primary outcome measure)
To demonstrate a difference in the relief of nighttime heartburn between esomeprazole 20 mg qd and placebo qd in patients with GERD as measured by a daily diary card [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00660660 on ClinicalTrials.gov Archive Site
To assess the impact of treatment with Esomeprazole 20mg versus placebo on sleep disturbances associated with GERD [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: Esomeprazole
    20mg once daily
    Other Name: Nexium
  • Drug: Placebo
    once daily
  • Experimental: 1
    Intervention: Drug: Esomeprazole
  • Placebo Comparator: 2
    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
240
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
  • Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
  • Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;

Exclusion Criteria:

  • Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
  • Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
  • Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00660660
D9612L00122
No
Tore Lind - Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Tore Lind, MD AstraZeneca
Study Director: Kurt Brown, MD AstraZeneca
Principal Investigator: David Johnson, MD Eastern Virginia Medical School
AstraZeneca
March 2009

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