The aim of present study is to determine whether adding buccal buspirone tablet as adjuvant to GERD treatment regimen in patients with GERD will improve the clinical symptoms.
Design
Design of the study is a triple-blind, placebo-controlled, randomized control single center clinical trial. Patients with age more than 15 years old with GERD will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 58 eligible patients with GERD compatible with inclusion criteria were chosen. patients were randomly divided into two control and intervention groups by Microsoft Excel software. and a code was allocated to each one of them.
Settings and conduct
This study is conducted as placebo controlled triple blinded randomized clinical trial in taleqani hospital participants, researcher & statistical data analyzer all has been blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: GERD Age more than 15 years old
Exclusion criteria: History of confirmed hypersensitivity reaction to buspirone or omeprazol or any parts of formulation
eGFR less than10 ml/min/1.73m2
Liver failure (child pugh C)
Pregnancy & lactation
concurrent use of MAOI/ conivaptane, tolvaptane/ thalidomide/ dapoxetine
Intervention groups
Intervention group (buccal buspirone): GERD patients compatible with inclusion/exclusion criteria administrated with 10mg buccal buspirone and 20 mg capsul omeprazol daily for1 mouths. Control group (buccal buspirone placebo): GERD patients compatible with inclusion/exclusion criteria administrated with 10mg buccal buspirone placebo and 20 mg capsul omeprazol daily for1 mouths
Main outcome variables
improvement of clinical symptoms of GERD disease (chest pain/ dyspepsia/ regurgitation / heart burn ) 1 months after initiation of buccal buspirone and omeprazole capsule
General information
Reason for update
Acronym
empty
IRCT registration information
IRCT registration number:IRCT20121021011192N7
Registration date:2019-01-10, 1397/10/20
Registration timing:registered_while_recruiting
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of buccal buspirone administration with placebo in improvement of clinical symptoms in GERD patients
Public title
buccal buspirone in GERD patients
Purpose
Treatment
Inclusion/Exclusion criteria
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/
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with Microsoft Excel software
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo buccal buspirone in same size, shape color, odor and package with real buccal buspirone which organized just by one responsible co-researcher has no involvement in running study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee school of pharmacy and nursing and midwifery- shahid Beheshti university of medical
Street address
School of Pharmacy, Nyayesh junction, Valiasr street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1397.129
Health conditions studied
1
Description of health condition studied
GERD
ICD-10 code
K21.9
ICD-10 code description
Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
Description
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 outcomes
1
Description
Record of Adverse drug reactions
Timepoint
During intervention
Method of measurement
Interview with patients
Intervention groups
1
Description
Intervention group: Addition of buspirone buccal tablet 10 mg/d to omeprazol capsule 20 mg/ d for treatment of GERD for 1 month
Category
Treatment - Drugs
2
Description
Control group: Addition of buspirone placebo buccal tablet 10 mg/d to omeprazol capsule 20 mg/ d for treatment of GERD for 1 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Talighani hospital
Full name of responsible person
Mohammad Abbasinazari
Street address
Valiasr street, nyayesh junction, School of pharmacy
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Naderi
Street address
School of Pharmacy, Nyayesh junction, Valiasr street,
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 9625
Email
naderi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
zahra sargashteh
Position
board certified clinical pharmacist
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 4044 8274
Email
zahra.sargashteh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Abbasinazari
Position
clinical pharmacy specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
m_abbasi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
zahra sargashteh
Position
board certified clinical pharmacist
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nyayesh junction, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 4044 8274
Email
zahra.sargashteh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available