This is a randomized double blind clinical trial. Eligible patients are ones with chief compliant of tinnitus without conductive hearing loss who referred to Amiralam hospital. Patients with severe illnesses and psychiatric diseases who need psychiatrist visit are excluded from the study. Patients are randomized into two group. Intervention group receive ondansetron and control group receive placebo with the same characteristics of main drug. This is a primary study for evaluating the effect of ondansetron on the symptoms of patients with tinnitus. Hence, we try to recruit patient with less restrictions to find subgroups who respond well to ondansetron. Sample size would be based on the time of the study. Primary outcomes are the scores of VAS, THI and TS and secondary outcomes are anxiety and depression scores based on HADS questionnaire and audio metric characteristics and pitch match and loudness match of the tinnitus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105185867N4
Registration date:2011-07-16, 1390/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-16, 1390/04/25
Registrant information
Name
Haydeh Samiee
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1857
Email address
hsamiee@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-05-18, 1390/02/28
Expected recruitment end date
2011-11-20, 1390/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ondansetron in patients with tinnitus: double blind control clinical trial
Public title
Ondansetron for tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are:
1) Patients with at least 6 month of tinnitus
2) 18 to 65 year old patients
3) Patients with chief compliant of tinnitus
4) Patients with sensorineural or normal hearing
Exclusion criteria:
1) Patients with severe illnesses and end stage diseases including liver, kidney and heart impairments. Patients with severe psychosis, dementia, cancers and those who are pregnant or lactating.
2) Patients with excessive problems and ones with psychiatric problems needing psychiatrist visit or ones who had an important surgery recently.
3) Patients with pulsatile tinnitus
4) Patients with worsening of tinnitus with head and neck movements
5) Patients on tinnitus treatment (including sound therapy, complements, drug...) unless still have tinnitus and have been remained on fix dosage of drug for more than acceptable time of action (for medications about 4 weeks).
6) Patients with cerumen impaction (unless tinnitus remained after cerumen removal)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics committee
Street address
Tehran University of Medical Sciences central building, Qods street, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2010-06-26, 1389/04/05
Ethics committee reference number
1045-48-01-89
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Tinnitus loudness based on VAS
Timepoint
At the beginnig and after 4 week
Method of measurement
Quesionnaire with 0 to 10 score
2
Description
Tinnitus handicapp scale(THI)
Timepoint
At the beginning and after 4 weeks
Method of measurement
Quesionnaire
3
Description
Tinnitus severity
Timepoint
At the beginnig and after 4 weeks
Method of measurement
Quesionnaire (Tinnitus severity index questionnaire)
Secondary outcomes
1
Description
SDS
Timepoint
At the begining and after 4 weeks
Method of measurement
Audiometry
2
Description
Depression and anxiety
Timepoint
At the beginning and after 4 weeks
Method of measurement
HADS quesionnaire
3
Description
Side effect
Timepoint
At the beginnig and after 4 weeks
Method of measurement
Quesionnaire
4
Description
Tinnitus loudness match
Timepoint
At the beginnig and after 4 weeks
Method of measurement
Audiometry
5
Description
Tinnitus pich match
Timepoint
At the beginnig and after 4 weeks
Method of measurement
Audiometry
6
Description
PTA
Timepoint
At the beginnig and after 4 weeks
Method of measurement
Audiometry
7
Description
SRT
Timepoint
At the begining and after 4 weeks
Method of measurement
Audiomtry
Intervention groups
1
Description
Ondansetron 16mg
for one month (4 tablets a day)
Category
Treatment - Drugs
2
Description
Placebo (4 tablet a day) for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
masoud motesady zarandy
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
6th floor, university central organization,qods street, keshavarz BLv
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shervin Taslimi
Position
MD-MPH
Other areas of specialty/work
Street address
ENT ward,Amiralam hospital, sadi street, Tehran
City
Tehran
Postal code
Phone
+98 912 387 0602
Fax
Email
taslimi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shervin Taslimi
Position
MD-MPH
Other areas of specialty/work
Street address
ENT ward,Amiralam hospital, sadi street, Tehran
City
Tehran
Postal code
Phone
+98 912 387 0602
Fax
Email
taslimi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shervin Taslimi
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
taslimi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)