The purpose of this study is evaluation and comparison of oral gabapentin and oral mirtazapine in management of uremic pruritus in dialysis patients suffering from chronic kidney disease.
Design
cross-over clinical trial, community-based and pragmatic, simple randomization,The sample volume is 60 people
Settings and conduct
This study was performed as a clinical, cross-over, on hemodialysis patient referring to Nephrology and Dialysis ward of Shahid-Beheshti Hospital and Besat Hospital of Hamadan.
Participants/Inclusion and exclusion criteria
Entrance criteria: aged over 18 years old, diagnosis of the end stage of kidney disease, who receive 3 times daily dialysis and suffer from moderate, severe or very severe uremic itching. Exit criteria: hyperphosphatemia, diabetic neuropathy, patients with psychiatric disorders Not able to cooperate.
Intervention groups
Intervention group 1: Patients receive oral 15 mg myrtazapine daily once a week for two weeks, and after two weeks of study and one week of purification, patients undergoing treatment with mirtazapin for two weeks are treated with gabapentin. The intervention group 2 :In gabapentin group, 100 mg of oral gabapentin is taken once daily for up to two weeks each day. After two weeks of study and a week of cleansing, gabapentin groups are treated with mirtazapine for two weeks.
Main outcome variables
Severity of itching in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150629022965N20
Registration date:2018-09-18, 1397/06/27
Registration timing:retrospective
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Mirtazapine and oral Gabapentin in treatment of uremic pruritus in hemodialysis patients
Public title
Effects f mirtazapine and gabapentin in treatment of uremic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged above 18
diagnosis of end stage renal disease
receiving dialysis 3 times a week
no history of dermatological disorder which result in feeling itch
no history allergen medications or foods
no history of receiving medication which relieve itch
presence of moderate, severe and very severe pruritus
Exclusion criteria:
pregnancy or lactation
presence of liver failure
presence of any psychiatric disorder
hyperfosfatemia
diabetic neuropathy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in the intervention group or control group by simple randomization method by sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517619651
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.UMSHA.REC.1396.622
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
severity of pruritus based on Visual analogue scale
Timepoint
daily for 5 weeks
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients were given 14 day, 15 mg once a day tablet of mirtazapin, from the company Schering-Plow, to prescribe uremic urea. After one week of washing, patients treated with 100 mg gabapentin daily will receive 14 days from Iran daroo, Iran.
Category
Treatment - Drugs
2
Description
Control group: Gabapentin is given 100 mg orally once a day for two weeks After a washout week, patients were given , 15 mg tablet of mirtazapin once a day,for 14 days , purchased from the company Schering-Plow Myrazapine, to control the uremic pruritus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Hamadan
Full name of responsible person
Dr Mahmood Gholiaf
Street address
Shahid Beheshti Hospital, Eram Blvd, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
3371-5-65179
Phone
+98 81 3838 0703
Email
gholyaf@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1010
Email
S_Bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran
City
Hmadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Yasrebifar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 21 4473 6694
Email
fateme.yasrebifar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available