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:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628342
First received: February 26, 2008
Last updated: March 11, 2009
Last verified: March 2009
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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:
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
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 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 May 23, 2013