In order to assess drug’s efficacy on tinnitus, 30 patients will be included in this controlled double blinded clinical trial study based on their medical status (no contra-indication to prescribing drug) and audiometric level of hearing . They will divide into 2 groups; half will receive 1998 mg/day acamprosate calcium and the other placebo tablets, for 4 weeks.
Through validated questionnaires, data such as level of tinnitus annoyance, tinnitus caused disturbance, quality of life, etc will be collected before, mid and after treatment.
Pure tone audiometry will be performed twice to confirm its equality.
Patients will undergo the oto-acoustic emission tests. These tests will be taken after the end of every treatment schedule. Changes in severity of tinnitus will be assessed through the results of audiometry, changes in OAE results, visual assessment scale (VAS) and loudness match in the end of a one month treatment. Patient will also be asked about the side effects of therapy if any.
Analysis would be proceeded after data gathered in excel sheets.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121115751N1
Registration date:2015-05-01, 1394/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-01, 1394/02/11
Registrant information
Name
Mohammad Mahdi Salem
Name of organization / entity
ENT, Head and neck surgery research center
Country
Iran (Islamic Republic of)
Phone
+98 912 233 5422
Email address
amasghari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran National Science Foundation
ENT, Head and Neck Surgery Research Center, Iran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-05, 1393/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acamprosate calcium in tinnitus: a double blind randomized and placebo controlled trial
Public title
Acamprosate calcium in tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Normal hearing or mild sensory-neural hearing loss and chronic idiopathic tinnitus(more than 3 months ); age between 18 to 65 years/old.
exclusion criteria: recent(less than a month) tinnitus treatment including sound or medical therapy; severe co-morbidities like renal, liver or cardiac diseases; malignancies; past history of treatment-required depression; previous ear surgery; alcohol user; opium or narcotic drugs abuser; pregnant women, lactation.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Iran university of medical sciences
Street address
Hemmar Highway, before sheikhfazlolah and ghamran highway cross
City
tehran
Postal code
Approval date
2015-01-14, 1393/10/24
Ethics committee reference number
93/105/4942
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
the measure of change in tinitus handicapp inventory
Timepoint
at the end of one month treatment
Method of measurement
audiometry, OAE, VAS, loudness match
Secondary outcomes
empty
Intervention groups
1
Description
Treatment Group with Acamprosate: taking 666mg/every 8 hr for a month ( if patient's weight is less than 60 kg, total dose will be half= 333mg/every 8 hr)
Category
Treatment - Drugs
2
Description
treatment group with placebo: taking 2 peals/ every 8hr for one month( if patient is less than 60 kg, total dose will be half=one peal/every 8hr)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Mohammad Mahdi Salem
Street address
ENT, Head and Neck Surgery Research Center, Rasool Akram Hospital, Niayesh str., Sattarkhan str.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Mohammad Farhadi
Street address
Fifth Alley, Next to Jalal Ale Ahmad Intersection, Northern Karegar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
ENT, Head and Neck Surgery Research Center
Full name of responsible person
Dr. Saeid Mahmoudian
Street address
Rasool akram hospital, Niayesh Str., Sattarkhan Str.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ENT, Head and Neck Surgery Research Center
Proportion provided by this source
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
3
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Salem
Street address
Hemmat freeway, next to Milad tower
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
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
ENT, Head and Neck Surgery Research Center
Full name of responsible person
Mohammad Mahdi Salem
Position
clinical resident
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh str., Sattarkhan str.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
mmsalem2@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ENT, Head and Neck Surgery Research Center
Full name of responsible person
Mohammad Mahdi Salem
Position
clinical resident
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh str., Sattarkhan str.
City
Tehran
Postal code
Phone
+98 64351
Fax
Email
mmsalem2@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ENT, Head and Neck Surgery Research Center
Full name of responsible person
Mohammad Mahdi Salem
Position
clinical resident
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh str., Sattarkhan str.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
mmsalem2@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)