This study is aimed for evaluation of pregabalin effect on symptoms of uremicrestless legs syndrome.
Inclusion criteria are as followed: End-stage renal disease, Restless legs syndrome
Exclusion criteria are as followed: Iron deficiency anemia, hypoglycemia, hyprcalcemia, treatment with drugs effective for RLS
The study population are a group a ESRD patients, admitted in dialysis ward of Imam Reza Hospital of Kermanshah. Sample size is 78 patients including intervention and control groups. Intervention include a period of 12 weeks treatment with pregabalin 50 mg once daily. Primary outcome is severity of RLS symptoms measured by questionnaire at the beginning and end of study and comparing between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072312685N9
Registration date:2017-08-20, 1396/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Hamidreza Omrani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6302
Email address
hamidomrani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pregabalin in treatment of uremic restless leg syndrome
Public title
Effect of pregabalin in treatment of uremic restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of ESRD; restless leg syndrome; signing of the informed consent.
Exclusion criteria:anemia; iron deficiency; treatment with other restless leg syndrome specific drugs; hypercalcemia; hypocalcemia; sensitivity to pregabalin; patient who reject cooprate for follow up
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science and Health Services
Street address
Shahid Beheshti ave. Kermanshah
City
Kermanshah
Postal code
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
Kums.rec.1396.185
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders
Primary outcomes
1
Description
Severity of restless legs syndrome symptoms
Timepoint
Beginning and end of study
Method of measurement
International restless legs syndrome study group rating scale(IRLS)questionnaire
Secondary outcomes
1
Description
Drug side effects
Timepoint
The entire study priod
Method of measurement
By patients report
Intervention groups
1
Description
pregabaline treatment with starting dose 50 mg once daily and gradually titrated up to 100 mg once daily it tolerated for a priod of 12 week.
Category
Treatment - Drugs
2
Description
The control group are treated with placebo for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Ward of Imam Reza Hospital
Full name of responsible person
Dr hamidreza Omrani MD Associate Professor, Dialysis ward
Street address
Imam Reza Hospital, Sorkheligeh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behruz Hamze Vice-Chancellor of Research and Technology
Street address
Shahid Beheshti Ave. Building n:2 of University
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
Internal Medicine Department of Kermanshah Faculty of Medicine
Full name of responsible person
Dr Shilan Haseli
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Sorkheligeh
City
Kermanshah
Postal code
Phone
+98 83 3427 6330
Fax
Email
Shilan.haseli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Internal Medicine Department of Kermanshah Faculty of Medicine
Full name of responsible person
Dr Hamidreza Omrani
Position
Associate Professor, Department of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Sorkheligeh
City
Kermanshah
Postal code
Phone
+98 83 3427 6330
Fax
Email
Hamidomrani@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Internal Medicine Department of Kermanshah Faculty of Medicine
Full name of responsible person
Dr Hamidreza Omrani
Position
Associate Professor Department of Nephrology
Other areas of specialty/work
Street address
Imam Reza Hospital, Sorkheligeh
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)