A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00626535
First received: February 21, 2008
Last updated: March 11, 2009
Last verified: March 2009
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Purpose
This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
| Condition | Intervention | Phase |
|---|---|---|
|
Symptomatic Gastroesophageal Reflux Disease (sGERD) |
Drug: Esomeprazole Drug: Matching placebo |
Phase 3 |
| 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 Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD) |
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:
- To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD [ Time Frame: Daily diary cards completed by the patient ]
Secondary Outcome Measures:
- To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD [ Time Frame: Daily diary cards completed by the patient ]
- To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD [ Time Frame: Percentage of days without upper abdominal pain over the 4-week treatment period ]
- To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment. [ Time Frame: Mean severity of the patient's upper abdominal pain over the last 4 weeks. ]
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2003 |
| Study Completion Date: | February 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
20mg once daily
|
Drug: Esomeprazole
20mg Oral Once Daily
Other Name: Nexium
|
|
Placebo Comparator: 2
Oral once daily
|
Drug: Matching placebo
Oral Once Daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of episodes of heartburn and upper abdominal pain for 6 months or longer.
- Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
- A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
Exclusion Criteria:
- Subjects with pain likely to be due to irritable bowel syndrome (IBS)
- History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Further 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: | NCT00626535 History of Changes |
| Other Study ID Numbers: | D9619C00001 |
| Study First Received: | February 21, 2008 |
| Last Updated: | March 11, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Symptomatic Gastroesophageal Reflux Disease (sGERD) Nexium Esomeprazole |
Additional relevant MeSH terms:
|
Abdominal Pain Gastroesophageal Reflux Pain Signs and Symptoms Signs and Symptoms, Digestive Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Omeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013