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buccal buspirone in GERD patients

comparison of the effect of buccal buspirone administration with placebo in improvement of clinical symptoms in GERD patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121021011192N7
Enrollment
58
Registered
2019-01-10
Start date
2018-10-22
Completion date
Unknown
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD. Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention 1: Intervention group: Addition of buspirone buccal tablet 10 mg/d to omeprazol capsule 20 mg/ d for treatment of GERD for 1 month. Intervention 2: Control group: Addition of buspirone pl

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: GERD disease in patients with more than 15 years old

Exclusion criteria

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/

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Record of Adverse drug reactions. Timepoint: During intervention. Method of measurement: Interview with patients.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactzahra sargashteh

Shahid Beheshti University of Medical Sciences

zahra.sargashteh@gmail.com+98 21 4044 8274

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026