buccal buspirone in GERD patients
Phase 3
Recruiting
- Conditions
- GERD.Gastro-esophageal reflux disease without esophagitis
- Registration Number
- IRCT20121021011192N7
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
GERD disease in patients with more than 15 years old
Exclusion Criteria
History of confirmed hypersensitivity reaction to buspirone or omeprazol or any parts of formulation of buccal buspirone
eGFR less than 10 ml/min/1.73m2
Liver failure (child pugh C)
Pregnancy & lactation
Concurrent use of thalidomide/ dapoxetine/MAOI/ conivaptane , tolvaptane/
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of clinical symptoms of GERD (chest pain / regurgitation / dyspepsia/heart burn). Timepoint: Before intervention and 30 days after initiation of daily use of buccal buspirone and capsule omeprazole. Method of measurement: Interview with patients based on FSSG questionnaire and quality of life questionnaire.
- Secondary Outcome Measures
Name Time Method Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.