Clinical trials with control group, with parallel groups, double blind, non-randomized
Settings and conduct
A group of patients with stuttering children aged 4 to 12 years old,
They are randomly divided into two groups. One group, in addition to undergoing speech therapy, is treated with a daily dose of 0.5 kg / mg
The car will also be placed, and the other will only be treated with speech therapies. Stuttering rate in both groups before and after 3 months
Treatment is based on the severity stuttering tool (SSI4), and the results will be compared. The other step is for
That the effect of the drug is proven apart from the effectiveness of speech therapies, the two groups will change together. So that the group treated with the drug this time
For 3 months only speech therapy will be received, and the group who did not receive the medication will receive both medication and speech therapies. Then again the results
Will be investigated and compared. In the case of efficacy, the drug will be evaluated in a blind, double-blind, and placebo-controlled trial.
Participants/Inclusion and exclusion criteria
All 4-12 year stuttering patients referred to Ardabil neurology clinic during a 2 month period
Intervention groups
Prescribing atomoxetine with a dose of 0.05 mg/kg daily for 3 months
Main outcome variables
severity of stuttering; SSI4 scoring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044247N1
Registration date:2019-08-13, 1398/05/22
Registration timing:prospective
Last update:2019-08-13, 1398/05/22
Update count:0
Registration date
2019-08-13, 1398/05/22
Registrant information
Name
Akram Motamedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 2251
Email address
amot314@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Atomoxetine on stuttering of children in 4-12 years old refering to neurological clinic in Ardabil
Public title
Evaluation of Atomoxetine on stuttering of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 4 to 12 year-old patients with stuttering.
Exclusion criteria:
Patients aged 12 to 4 years with stuttering with brain or evolutionary problems.
Patients aged 4 to 12 years with stuttering do not go on a three-month follow-up to continue treatment.
Patients aged 4 to 12 years with stutter, who are treated with a drug other than atomextin.
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients referred to the neurology clinic will be arranged in the order of referral in the intervention group with the main drug and placebo group. The medication will be prescribed for a period of three months. At the end of the three months, the group who received the original drug will be given a placebo and the placebo group will receive the original drug (atomoxetine).
Placebo
Used
Assignment
Parallel
Other design features
In this project intervention group and placebo group will change to eradicate influence of speech therapy on results.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee of Ardabil Medical Science University,National Ethics Committee for Biomed
Beginning of intervention and end of the 3 month period
Method of measurement
Severity Measurement Tool SSI4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Including 50 patients who will be referred to the Pediatric Neurology Clinic for 2 months and randomly assigned to the Atomoxetine treatment group. This group will take the drug for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients.
Category
Treatment - Drugs
2
Description
Control group: Including 50 patients who will be referred to the pediatric neurology clinic within 2 months and will be randomly assigned to a placebo treatment group. This group will use placebo for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients.
Category
Placebo
3
Description
Intervention group: This group includes the same 50 patients in control group 1 who will receive atomoxetine for another 3-month period. Standard stuttering (speech therapy) will also continue for this group.
Category
Treatment - Drugs
4
Description
Control group: This group includes the same 50 patients in intrvention group 1 who will receive placebo for another 3-month period. Standard stuttering (speech therapy) will also continue for this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatrics Neurologic clinic
Full name of responsible person
Farzad Ahmadabadi
Street address
Boali Pediatric Hospital, Varzesh square, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613643197
Phone
+98 45 3325 2251
Fax
+98 45 3323 3055
Email
Farzadpt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab Bohlooli
Street address
Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3352 2247
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Akram Motamedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Boali Pediatrics hospital, Varzesh square
City
Ardabil
Province
Ardabil
Postal code
5613643197
Phone
+98 45 3325 2251
Email
amot314@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Akram Motamedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Stair 2, No 159, Golchin2 Ave, Shahrak Naderi, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613643197
Phone
+98 45 3325 2251
Fax
Email
amot314@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Akram Motamedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Stair 2, No 159, Golchin2 Ave, Shahrak Naderi, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613643197
Phone
+98 45 3325 2251
Fax
Email
amot314@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will include the efficacy of Atomoxtein on the severity of stuttering.
The main characteristics of the patients, including their first name, will not be published.
Other general specifications, including age and sex, and the extent to which they are communicated and their effect on stuttering, will be provided.
When the data will become available and for how long
Since the beginning of 1399
To whom data/document is available
Academic or non-academic researchers
Under which criteria data/document could be used
Using the results of the study with its source is allowed
From where data/document is obtainable
Ardabil University of Medical Sciences at www.arums.ac.ir
What processes are involved for a request to access data/document
By accessing the site of Ardabil University of Medical Sciences, you can access the information of this research by selecting the library's digital library option.