Effect of Pregabalin on Functional Dyspepsia, A Randomized Controlled Study
Phase 3
Completed
- Conditions
- Functional DyspepsiaSelf report of adequate reliefNapean dyspepsia IndexSelf report of adequate reliefFunctional dyspepsiaPregabalinNapean dyspepsia Index
- Registration Number
- TCTR20200404002
- Lead Sponsor
- Chiang Mai University
- Brief Summary
Pregabalin was effective in FD patients, especially in patients with predominant pain and burning symptoms; Its benefit was significantly exhibited on 4 weeks after starting treatment. The concerning side effect was dizziness, which seemed to be tolerable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
Diabnosed Funtional dypsepsia according to Rome IV criteria
Normal esophagogastroduodenoscopy within 5 years
No evidence of Helicobacter pylori infection
Partial or non responsder to proton pump inhibitor as standard treatment
Exclusion Criteria
History of irritable bowel syndrome
Major physical illness e.g. End stage kidney disease
Pregnancy and Lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self Report of Adequate Relief Week 4, Week 8 Score
- Secondary Outcome Measures
Name Time Method Short form Napean dyspepsia index Baseline, Week 4, Week 8 Score