NCT00222131

Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Inhibition of Gastric Acid Is the Key To Satisfactory Relief of Symptoms and Restoration of the Quality of Life in Patients With Epigastric Pain Related to Non-Ulcer Dyspepsia During Therapy With Esomeprazole

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Detailed description

Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

Conditions

• Indigestion

Interventions

Type	Name	Description
DRUG	Esomeprazole	Esomeprazole 40 mg QD
OTHER	Placebo	Placebo

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-09-22
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States