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CompletedNCT00626535Updated Mar 12, 2009

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)

A Phase 3 interventional study of Esomeprazole and Matching placebo in Symptomatic Gastroesophageal Reflux Disease (sGERD), sponsored by AstraZeneca. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Symptomatic Gastroesophageal Reflux Disease (sGERD)

Keywords

  • Symptomatic Gastroesophageal Reflux Disease (sGERD)
  • Nexium
  • Esomeprazole
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 500 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    1

    20mg once daily

    Drug: Esomeprazole

  • Placebo comparator
    2

    Oral once daily

    Drug: Matching placebo

Interventions

  • DrugEsomeprazole

    20mg Oral Once Daily

    Also known as: Nexium

  • DrugMatching placebo

    Oral Once Daily

06

What researchers measure

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

    Time frame: Daily diary cards completed by the patient

Secondary 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 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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00626535
Lead sponsor
AstraZeneca
First posted
Feb 29, 2008
Start date
Mar 2003
Primary completion
Feb 2004
Completion
Feb 2004
Last update
Mar 12, 2009

Study contacts

Paula Fernstrom
study director · Nexium Global Product Director, AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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