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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)

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ClinicalTrials.gov Identifier: NCT00626535
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Symptomatic Gastroesophageal Reflux Disease (sGERD) Drug: Esomeprazole Drug: Matching placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : March 2003
Primary Completion Date : February 2004
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626535


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

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00626535     History of Changes
Other Study ID Numbers: D9619C00001
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Nexium
Esomeprazole

Additional relevant MeSH terms:
Gastroesophageal Reflux
Abdominal Pain
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action