Objective: This study is designed to evaluate the efficacy of Topiramate on pain in diabetic polyneuropathy and compare it with the known drug Gabapentin.
Design: This study is a clinical trial in Mostafa Khomeini Hospital performed on patients with painful diabetic polyneuropathy. All cases are simply divided in two group equally.
Setting and conduct: One hundred patients selected in intervention group named group one and take Topiramate one hundred milligram daily twelve weeks and patients in group two (control group) take Gabapentin nine hundred milligrams daily for the same period. Pain intensity is evaluated every two weeks in both groups with visual analogue scale (VAS) which is a standard scale for pain intensity. Study design and aims are explained completely for all patients and all patients have a written consent. The coworkers who evaluate the patieints are blinded to drugs. Selected patients are between 35 to 75 years old with at least 8 years history of diabetes. Patients with any history pain to other causes, use of other pain killer drugs or any history of allergy to the above drugs are not permitted in this study. Thirty millimeter decrease in VAS score is a significant response. The main aim of this study is searching drug for helping to relieve pain in patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110330680N1
Registration date:2017-02-04, 1395/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-04, 1395/11/16
Registrant information
Name
Siamak Afshinmajd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9438
Email address
afshin@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed university. This study is a dissertation in general medicine degree.
Expected recruitment start date
2008-12-31, 1387/10/11
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of Topiramate Efficacy On Neuropathic Pain In Patients
With Diabetic Polyneuropathy
Public title
Topiramate In Diabetic Polyneuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35t0 75 years old;
painful diabetic polyneuropathy;
more than 8 year duration of disease;
Exclusion criteria:
Pain due to other cause;
Taking any other pain killer drugs;
History of allergy to drugs;
Do not meet the criteria of ethical committee of shahed University;
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients who meet the criteria of study select by researchers assigned every other in intervention and control groups. Coworkers who are blind to group of patients or kind of drug evaluate the patients and finally patients complete the questionnaire.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Shahed University
Street address
Shahed University, Infront Of Emam Khomeini Tomb, Khalije Fars High Way
City
Tehran
Postal code
00982166495832-4
Approval date
2007-10-16, 1386/07/24
Ethics committee reference number
Shahed.REC.1386.1
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy (E10-E14 with common fourth character .4+)
Primary outcomes
1
Description
Pain In Diabetic Polyneuropathy
Timepoint
In the beginning of study and then every two weeks to three months
Method of measurement
Questionnaire Completed By Researchers And International Standard Scale Of (VAS)
Secondary outcomes
1
Description
Drowsiness
Timepoint
Every two weeks
Method of measurement
Questionnaire Completed By researchers from patient complaints
2
Description
redness or pruritus of skin(hypersensitivity to drugs)
Timepoint
Two weeks after starting the study and then every two weeks for twelve weeks
Method of measurement
Questionnaire completed By researchers and question from patients
Intervention groups
1
Description
Group One(Intervention)
All the selected patients are treated with Topiramate one hundred milligrams daily at night . Dose escalation is gradually over three weeks and patients are evaluated by VAS scale each two weeks for three months
Category
Treatment - Drugs
2
Description
Group Two (control),All patients treat by Gabapentin nine hundred milligrams daily divided in three hundred milligram every eight hour. Pain intensity is measured every two weeks for twelve weeks by VAS scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Hospital Manager or Education Secretary
Street address
Italia Street, Keshavarz. Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Zahra Kiasalari, Head Of Research Department.
Street address
Research Department, Shahed University, Tehran-Qom Highway
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, Shahed University
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
Associate Professor Of Neurology.Neurophysiology Research Center.Shahed University
Full name of responsible person
Siamak Afshin majd
Position
Neurologist
Other areas of specialty/work
Street address
Italia, ST. Keshavarz, Blvd.
City
Tehran
Postal code
Phone
+98 21 8896 9438
Fax
Email
afshin@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Associate Professor Of Neurology, Neurophysiology Research Center, Shahed University
Full name of responsible person
Siamak Afshin majd
Position
Neurologist
Other areas of specialty/work
Street address
Italia ,ST. Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8896 9438
Fax
Email
afshin@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Associate Professor Of Neurology,Neurophysiology Research Center,Shahed University
Full name of responsible person
Siamak Afshin majd
Position
Neurologist
Other areas of specialty/work
Street address
Italia, ST. Keshavarz, Blvd.
City
Tehran
Postal code
Phone
+98 21 8896 9438
Fax
Email
afshin@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)