Comparative study of the effect of gabapentin and pregabalin on neuropathy caused by Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in patients
Comparative study of the effect of gabapentin and pregabalin on neuropathy caused by Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in patients
Design
Clinical trial with control group with parallel groups, phase 2-3 on 40 patients
Settings and conduct
This study is performed in Al-Zahra Hospital in Esfahan. Patients will be treated in two ways and the response rate will be assessed by a questionnaire within 1 year.
Participants/Inclusion and exclusion criteria
Inclusion criteria: CIDP-induced neuropathy based on neurologist diagnosis, age over 18 years, no other underlying disease that causes neuropathy, and satisfaction with participation in this study.
Exclusion criteria: hypersensitivity to venlafaxine, gabapentin and pregabalin, and dissatisfaction with continuing the study
Intervention groups
Intervention group 1: Patients in the first group will be treated with 37.5 mg of venlafaxine daily with 100 to 500 mg of gabapentin daily. This treatment will continue for patients for 12 months. All questionnaires will be completed by patients before the intervention and once every three months for a year (12 months after treatment). Intervention group 2: Patients in the second group will be treated with venlafaxine 37.5 mg and pregabalin 50 to 300 mg daily. This treatment will continue for patients for 12 months. All questionnaires will be completed by patients before the intervention and once every three months for a year (12 months after treatment).
Main outcome variables
Intensity of patients' body pain and severity of neuropathic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N16
Registration date:2021-06-13, 1400/03/23
Registration timing:prospective
Last update:2021-06-13, 1400/03/23
Update count:0
Registration date
2021-06-13, 1400/03/23
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-08, 1400/05/17
Expected recruitment end date
2021-09-08, 1400/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of gabapentin and pregabalin on neuropathy caused by Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in patients
Public title
gabapentin and pregabalin on neuropathy caused by Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
CIDP-induced neuropathy based on neurologist diagnosis
Age over 18 years
No other underlying disease that causes neuropathy
Satisfaction with participation in this study
Exclusion criteria:
Hypersensitivity to venlafaxine, gabapentin and pregabalin
Dissatisfaction with continuing the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUI.MED.REC.1398.070
Health conditions studied
1
Description of health condition studied
Chronic inflammatory demyelinating polyneuropathy
ICD-10 code
G61
ICD-10 code description
Inflammatory polyneuropathy
Primary outcomes
1
Description
Intensity of patients' body pain
Timepoint
Before the intervention and once every three months for a year
Method of measurement
Visual Analogue Scale
2
Description
Severity of neuropathic pain
Timepoint
Before the intervention and once every three months for a year
Method of measurement
Short form of McGill Pain Questionnaire (SF-MPQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in the first group will be treated with 37.5 mg of venlafaxine daily with 100 to 500 mg of gabapentin daily. This treatment will continue for patients for 12 months. All questionnaires will be completed by patients before the intervention and once every three months for a year (12 months after treatment).
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in the second group will be treated with 37.5 mg of venlafaxine daily and pregabalin 50 to 300 mg daily. This treatment will continue for patients for 12 months. At the beginning of the intervention, as well as once every three months for a year, all questionnaires for patients will be completed and compared with the other group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Keyvan Basiri
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
h.hemasian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Keyvan Basiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
basirikeivan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keyvan Basiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
basirikeivan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keyvan Basiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
basirikeivan@gmail.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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.