Determining the effectiveness of gabapentin topical cream in improving itching in dialysis patients
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 80 patients. We use a table of random numbers for randomization.
Settings and conduct
Patients of Al-Zahra, Khorshid and Amin dialysis centers who have the conditions to enter the study are randomly divided into 2 groups. To randomize the samples, we use the table of random numbers.
The creams prepared in this study are named into two groups No. 1 and 2, one of which is Gabapentin topical cream and the other is placebo, which includes the cream base. Unaware to observe the three-blindness of the study.
Participants/Inclusion and exclusion criteria
Target community patients with pruritus ani. The itching studied in this study should be itching of the whole body except the head, face and neck.
Intervention groups
One group is given cream number 1 and the other group is given cream number 2. Patients receive the creams for 4 weeks.
The dose is used once a day for itchy areas of the body, but more than 50 grams per week (equivalent to one tube) should not be used and will be followed for 4 weeks after that.
Main outcome variables
Determining the mean changes in pruritus score before and after application of gabapentin topical cream according to age, sex, duration of dialysis initiation and underlying cause of dialysis. The possible skin complication of topical gabapentin cream is also examined.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220306054206N1
Registration date:2022-03-17, 1400/12/26
Registration timing:prospective
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Parisa Mohamadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 8056
Email address
parisa.m@edu.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of gabapentin topical cream in improving itching of end-stage renal disease to dialysis
Public title
The effect of gapentin cream on pruritus in dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Target community patients with pruritus ani. The itching studied in this study should be itching of the whole body except the head, face and neck.
Exclusion criteria:
Itching of the head, neck and face
Other simultaneous skin diseases on the trunk and limbs
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the samples, we use the table of random numbers. For this purpose, we give a number to each person who has a dialysis file, and then, based on the random number table, the first 40 numbers of drug number 1 and the next 40 numbers of drug number 2 are given.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The creams prepared in this study are named into two groups No. 1 and 2, one of which is Gabapentin topical cream and the other is placebo, which includes the cream base. Unaware to observe the three-blindness of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Azadi Square, Hezar Jerib St., School of Medicine - Isfahan University of Medical Sciences (Research Ethics Committee)
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-02-19, 1400/11/30
Ethics committee reference number
IR.MUI.MED.REC.1400.808
Health conditions studied
1
Description of health condition studied
Itching end-stage renal disease leading to dialysis
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Determining the effectiveness of gabapentin topical cream in improving itching in dialysis patients
Timepoint
Patients receive medication for 4 weeks and are followed up for 4 weeks thereafter
Method of measurement
Two questionnaires are used to score patients' pruritus: 12-item and 5-item
Secondary outcomes
1
Description
Determining the mean changes in pruritus score before and after application of Gabapentin topical cream according to age and sex, duration of dialysis initiation and underlying cause of dialysis
Timepoint
Patients receive medication for 4 weeks and are followed up for 4 weeks thereafter
Method of measurement
By two questionnaires: 12-item and 5-item
Intervention groups
1
Description
Intervention group: Gabapentin will be dissolved in the liquid phase, and finally 5% gabapentin cream will be prepared in water-based cold cream type oil. It is used once a day for 4 weeks on itchy areas, but do not consume more than 50 grams per week.
Category
Treatment - Drugs
2
Description
Control group: The drugs in this group can be used as a cream-based placebo. It can be taken once a day on itchy areas, but it should not be taken more than 50 grams per week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مََرکز دیالیز الزهرا ,خورشید و امین
Full name of responsible person
Parisa Mohammadian
Street address
Hakim Nezami Three Ways, Shohada Sofeh Street, Al-Zahra Hospital. Khorshid Hospital Governorate Street. Ibn Sina St. Amin Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Azadi Square, Hezar Jarib St., Isfahan University of Medical Sciences, Vice Chancellor for Research and Technology
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
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
Parisa Mohamadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 119, Kave Ave, Aref
City
Esfahan
Province
Isfehan
Postal code
8194862311
Phone
+98 31 3444 8056
Fax
Email
parisa.m@edu.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gita Faghihi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi Square, Hezar Jerib St., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8194862311
Phone
+98 31 3668 7898
Fax
Email
g_faghihi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Mohamadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 119, Kave Ave, Aref
City
Esfahan
Province
Isfehan
Postal code
8194862311
Phone
+98 31 3444 8056
Fax
Email
parisa.m@edu.mui.ac.ir
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
Statistical data are generally shared. In other words, each person's data is not displayed alone, but their overall results and averages are shared with the statistical analysis method.
When the data will become available and for how long
Data access time 3 months after printing the results
To whom data/document is available
Any researcher can apply for data
Under which criteria data/document could be used
They can access the data if similar research is underway and they submit evidence of the study.
From where data/document is obtainable
Via email parisa14m@yahoo.com to Parisa Mohammadian
What processes are involved for a request to access data/document
They will have access to the data within a maximum of one month after sending the documents stating that the following project has been completed