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Completed

NCT Number: NCT00626535

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 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)

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Key information

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

20mg Oral Once Daily

Other names: Nexium

Matching Placebo

Drug

Oral Once Daily

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Feb 29, 2008
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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