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IV Pantoprazole for Dyspeptic Pain
NCT01281501Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2011
- Primary completion
- Oct 2011
- Countries
- 1
- Sponsor
- Chulalongkorn University
- Modality
- Small Molecules
- Drugs
- pantoprazole
- Conditions
- dyspepsia
01
Overview
Phase 4, randomised, double-blind trial of pantoprazole in dyspepsia (2 arms), sponsored by Chulalongkorn University. Primary endpoint: Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment. Started Jan 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Conventional
Oral antacid + IV hyoscine butylbromide + Normal saline
Pantoprazole
Oral antacid + IV hyoscine butylbromide + IV pantoprazole
03
Who it enrols
Patients with clinical diagnosis of acid-related dyspepsia, age 15-50, and severe pain (VAS >= 5.0). Excludes those with malignancies, major medical problems, or recent use of acid antisecretory agents.
04
Endpoints
Primary
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Secondary
Number of Participants in the Predefined 'Responders'
Number of Participants in the Predefined 'Non-responders'
Number of Participants With Adverse Effect
Number of Participants That Have Overall Satisfaction on the Treatment
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