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The comparative study of combination Gabapentin and topiramate vs treatment alone topiramate or Gabapentin of painful diabetic neuropathy

Protocol summary

Summary
The aim of this study is to compare the effects of combination of gabapentin and topiramate with gabapentin or topiramate monotherapy in the treatment of painful diabetic neuropathy. In this randomized clinical trial, 150 patients with diabetes from the Kermanshah Diabetes Research Center for treatment of painful diabetic neuropathy will be randomly divided into three groups (n=50). In first group, treatment started with 50mg/daily topiramate and patients visited respectively at day 15, 30, 60 and 90 and drug dose increases based on treatment response and patient tolerance if necessary, respectively, 100, 200, and maximize 400 mg. In second group, gabapentin started by 300 mg/daily and like the first groups are examined. The third group combination of 25mg topiramate and 100mg gabapentin will start and on the basis of response to treatment and patient tolerance the dose will increased. At the end of treatment improvement of painful diabetic neuropathy, changes in HbA1c, cholesterol, triglyceride changes and patient weight in the three groups will compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108287432N1
Registration date: 2012-01-12, 1390/10/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-12, 1390/10/22
Registrant information
Name
Parviz Soufivand
Name of organization / entity
Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1837 2910
Email address
psoufivand@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-11-16, 1390/08/25
Expected recruitment end date
2012-05-14, 1391/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of combination Gabapentin and topiramate vs treatment alone topiramate or Gabapentin of painful diabetic neuropathy
Public title
The comparative study of combination Gabapentin and topiramate vs treatment alone topiramate or Gabapentin of painful diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: 1 - diabetes Type II 2 - Dissatisfaction at entering the study, 3 - Failure to receive medication to control pain when the study began, 4 - exposure to neuropathic pain from diabetes. Exclusion criteria: kidney disease - pregnancy - breastfeeding - a history of liver disease - while taking anti-seizure- taking OCP - a history of sensitivity to Astazvlamydya - other causes for neuropathy, such as MS-CVA
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Kermanshah university of medical sciences
Street address
Shahid beheshti Blvd
City
Kermanshah
Postal code
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
2000305

Health conditions studied

1

Description of health condition studied
Diabetic neuropathy
ICD-10 code
E10.4
ICD-10 code description
Insulin-dependent diabetes mellitus with neurological complications

Primary outcomes

1

Description
improvement of painful diabetic neuropathy
Timepoint
Day 15, 30, 60 and 90
Method of measurement
Based on TCSS

Secondary outcomes

1

Description
changes in HbA1c
Timepoint
Day 15, 30, 60, 90
Method of measurement
Based on laboratory assessment

2

Description
changes in triglycerid
Timepoint
Day 15, 30, 60, 90
Method of measurement
based on laboratory assessment

3

Description
changes in cholestrol
Timepoint
Day 15, 30, 60, 90
Method of measurement
based on laboratory assessment

Intervention groups

1

Description
In second group, gabapentin started by 300 mg/daily and like the first groups are examined.
Category
Treatment - Drugs

2

Description
In first group, treatment started with 50mg/daily topiramate and patients visited respectively at day 15, 30, 60 and 90 and drug dose increases based on treatment response and patient tolerance if necessary, respectively, 100, 200, and maximize 400 mg.
Category
Treatment - Drugs

3

Description
The third group combination of 25mg topiramate and 100mg gabapentin will start and on the basis of response to treatment and patient tolerance the dose will increased
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Diabetes Research Center
Full name of responsible person
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
No. 2, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. MehrAli rahimi
Position
Endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Interanl medicin group
City
Kermanshah
Postal code
Phone
+98 83 1427 6314
Fax
Email
m.javadra@yahoo.comm.javadra@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. MehrAli Rahimi
Position
Endocrinologist
Other areas of specialty/work
Street address
Imam reza hospital- Internal medicine group
City
Keramnshah
Postal code
Phone
+98 83 1427 6314
Fax
Email
m.javadra@yahoo.comm.javadra@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parviz Soufivand
Position
Internal medicine resinent
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 83 1427 6314
Fax
Email
psoufivand@kums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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