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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)

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Symptomatic Gastroesophageal Reflux Disease (sGERD)

Intervention: Esomeprazole (Drug); Matching placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca

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)

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

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

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

To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: March 2003
Last updated: March 11, 2009

Page last updated: August 23, 2015

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