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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626535
First Posted: February 29, 2008
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
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)

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: February 21, 2008
First Posted: February 29, 2008
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