60 patients with signs and symptoms of laryngopharyngeal reflux meeting will enter the study. The patients will be allocated randomly to three subgroups. The first, second and third group will recieve Omeprazole, Pantoprazole, and Esomeprazole, respectively, for three months by the dose suggested in previous studies. The severity of symptoms and signs will be evaluated using predesigned data sheets and self-instructed forms and based on laryngoscopic findings prior to and three months after treatment. The drugs are provided in boxes without any labels. The data reviewer is also blinded to the patients groups. Finally the symptoms scores and laryngoscopic findings will be compared with previous findings.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050133277N2
Registration date:2017-06-02, 1396/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Mehrdad Jafari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
m-jafari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Otorhinolaryngology research center, Tehran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Omeprazole, Pantoprazole and Esomeprazole in treatment of laryngopharyngeal reflux
Public title
Comparison of the effect of Omeprazole, Pantoprazole and Esomeprazole in treatment of laryngopharyngeal reflux
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: presence of symptoms of laryngopharyngeal reflux; presence of signs of laryngopharyngeal reflux in pharyngeal examinations
Exclusion criteria: Recent treatment with antireflux drugs; history of sergury on Stomach and esophagus; history of connective tissue diseas; any benign or malignant lesions of larynx; recieving antiinflammatory drugs either systemic or inhalational
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.TUMS.VCR.REC.1395.983
Health conditions studied
1
Description of health condition studied
Gastro-oesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-oesophageal reflux disease
Primary outcomes
1
Description
Globus sensation
Timepoint
before treatment then 3months later
Method of measurement
History
2
Description
number of days with reflux
Timepoint
before treatment then 3months later
Method of measurement
history
3
Description
Posr nasal discharge
Timepoint
before treatment then 3months later
Method of measurement
history
4
Description
Vocal cord errythema
Timepoint
Befaore and three months after treatment
Method of measurement
Laryngoscopy
5
Description
Supraglottic edema
Timepoint
Before and three months after treatment
Method of measurement
Laryngoscopy
6
Description
Severity of cough
Timepoint
before treatment then 3months later
Method of measurement
history
7
Description
Cough after meals or when lying down
Timepoint
before treatment then 3months later
Method of measurement
history
8
Description
Hoarseness
Timepoint
Before and three months after treatment
Method of measurement
Questionnaire
9
Description
Heartburn and acid rising feeling
Timepoint
before treatment then 3months later
Method of measurement
history
10
Description
Difficulty swallowing
Timepoint
before treatment then 3months later
Method of measurement
taking history
11
Description
Difficult breathing
Timepoint
before treatment then 3months later
Method of measurement
taking history
12
Description
Interarytenoid edema
Timepoint
Before and three months after treatment
Method of measurement
Laryngoscopy
Secondary outcomes
empty
Intervention groups
1
Description
tab Esomeprazole 40mg, po, BD for 3 months
Category
Treatment - Drugs
2
Description
Tab Pantoprazole 40 mg, po, BD for 3 months
Category
Treatment - Drugs
3
Description
Tab Omeprazole 40 mg, po, BD for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Nadia Shafiei
Street address
Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Science