Object: Comparison of antipruritic effects of pregabalin with doxepin in the management of uremic pruritus in patients with end stage renal disease undergoing dialysis.
Method: 70 patients, aged 16 to 80 years, will be randomly assigned to pregabalin or doxepin.
Starting dose of pregabalin is 50 mg three times per week. If response to the medication is not satisfactory, dose of pregabalin will be increased to 50 mg per day. Starting dose of doxepin is 10 mg daily. If response to the medication is not satisfactory, dose of doxepin will be increased to 10 mg two times per day. Patients will be evaluated with 5-D itch scale, visual analogue scale and dermatology life quality index before the intervention and one week, two weeks and four weeks after the intervention. Moreover, adverse effects will be evaluated by checklist of adverse effects at the end of the first and fourth weeks of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060922637N1
Registration date:2015-08-29, 1394/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-29, 1394/06/07
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregabalin with doxepin in the management of uremic pruritus
Public title
Comparison of pregabalin with doxepin in the management of uremic pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 16-80 years old; undergoing regular hemodialysis or peritoneal dialysis
Exclusion criteria: history of allergy to pregabalin or doxepin; liver failure; pregnancy; history of epilepsy or a single episode of seizure; uncontrolled psychiatric illness; decompensated heart failure; narrow angle glaucoma; hyperthyroidism; history of myocardial infarction in the past three months; heart block; low blood pressure(Systolic blood pressure less than 90 mmHg)
Age
From 16 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics committee of Kerman University of Medical Sciences
Street address
Research assistance office of Kerman University of Medical Sciences, Ebne-Sina street
City
Kerman
Postal code
7619813159
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
IR.KMU.REC.1394.120
Health conditions studied
1
Description of health condition studied
ESRD
ICD-10 code
N 18.5
ICD-10 code description
End stage kidney disease on dialysis
Primary outcomes
1
Description
Severity of pruritus
Timepoint
Before the intervention, and one week, two weeks and four weeks after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Severity of pruritus and its impact on the quality of life
Timepoint
Before the intervention, and one week, two weeks and four weeks after the intervention
Method of measurement
5-D itch scale
2
Description
Effect of pruritus on the quality of life
Timepoint
Before the intervention and one week, two weeks and four weeks after the intervention
Method of measurement
Dermatology Life Quality Index (DLQI)
3
Description
Adverse effects
Timepoint
At the end of the first and fourth weeks of the intervention
Method of measurement
Checklist of adverse effects
Intervention groups
1
Description
Pregabalin (Oral Capsule 50 mg): The initial dose of pregabalin is 50 mg three times a week (after each dialysis session in hemodialysis patients). After one week, if response to the medication is not satisfactory, dose will be increased to 50 mg per day. ِDuration of the study is 4 weeks.
Category
Treatment - Drugs
2
Description
Doxepin (Oral Capsule 10 mg): The initial dose of doxepin is 10 mg per day. After 1 week, if response to the medication is not satisfactory, dose of the drug will be increased to 10 mg two times per day. Duration of the study is four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Naemeh Nikvarz
Street address
Kowsar Boulevard
City
Kerman
2
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Naemeh Nikvarz
Street address
Imam Khomeini Highway
City
Kerman
3
Recruitment center
Name of recruitment center
Javad-ol Aemeh Dialysis Center
Full name of responsible person
Naemeh Nikvarz
Street address
Alley No 25, North Abouzar Street
City
Kerman
4
Recruitment center
Name of recruitment center
Ali-ebne Abitaleb Hospital
Full name of responsible person
Nazanin Foroutan
Street address
West Mofateh Boulevard, Ali-ebne Abitaleb Square
City
Rafsanjan
5
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Nazanin Foroutan
Street address
Ebne sina Street
City
Sirjan
6
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Nazanin Foroutan
Street address
Pasdaran Alley, Chamran Street
City
Zarand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mrs. Hasani
Street address
Office of research affair of Kerman University of Medical Sciences, Ebne-Sina Street
City
Kerman
Grant name
Grant code / Reference number
94/109
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant Professor/PhD
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft-Bagh Boulevard
City
Kerman
Postal code
7616911319
Phone
+98 34 3121 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
PhD/Assistant professor
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft-Bagh Boulevard
City
Kerman
Postal code
7616911319
Phone
+98 34 3121 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nazanin Foroutan
Position
General Doctor of Pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft-Bagh boulevard
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5003
Fax
+98 34 3132 5003
Email
nfrootan.nazanin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)