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)

NCT00626535 | Completed Phase 3

• 1 other identifier: D9619C00001
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Keywords

Symptomatic Gastroesophageal Reflux Disease (sGERD); Nexium; Esomeprazole

Outcome Measures

Primary Outcomes (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

  Daily diary cards completed by the patient

Secondary Outcomes (3)

• 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

  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

  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.

  Mean severity of the patient's upper abdominal pain over the last 4 weeks.

Study Arms (2)

1

EXPERIMENTAL

20mg once daily

Drug: Esomeprazole

2

PLACEBO COMPARATOR

Oral once daily

Drug: Matching placebo

Interventions

Esomeprazole DRUG

20mg Oral Once Daily

Also known as: Nexium

1

Matching placebo DRUG

Oral Once Daily

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: March 1, 2003
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: March 12, 2009

Record last verified: 2009-03