Studying safety and efficacy of Bumetanide on relief of pharmacological treatment-resistant pain in spinal cord injury patients refered to pain clinic of Brain And Spinal Cord Injury Research Center, Emam Khomeini Hospital, Tehran, during years 1392 through 1393
The aim of this study is to assess the clinical effect of bumetanide on central neuropathic pain in patients with spinal cord injury. The population under study in this nonrandomized, non-blind, uncontrolled, unicentral, phase 1/2 trial is spinal cord injury-induced pain patients with refractory pain despite at least four weeks of medical treatment. Between 10 to 15 cases would be enough for the study. All the patients which sign the informed consent and do not have exclusion criteria including history of renal failure, creatinin more than 1.5, history of cardiac diseases, evidence of hypokalemia or using medications cross-reacting with bumetanide would be included in the study. Bumetanide tablets would be administered for the patients during four months of study and the effect on pain would be assessed by questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407155368N2
Registration date:2014-08-19, 1393/05/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-19, 1393/05/28
Registrant information
Name
Mahmoudreza Hadjighassem
Name of organization / entity
Brain and Spinal Cord Injury research center, SAchool of advanced medical technologies, Tehran Unive
Country
Iran (Islamic Republic of)
Phone
+98 21665815601
Email address
drhadjighassem@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Brain and Spinal Cord Injury Research Center, Emam Khomeini Hosp.,Tehran
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying safety and efficacy of Bumetanide on relief of pharmacological treatment-resistant pain in spinal cord injury patients refered to pain clinic of Brain And Spinal Cord Injury Research Center, Emam Khomeini Hospital, Tehran, during years 1392 through 1393
Public title
Bumetanide Effect on SCI pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All the patients with spinal cord injury and refractory at- or below-level pain due to the injury who signed the informed consent.
Exclusion Criteria: History of renal failure; Creatinine more than 1.5 mg/dl or its increase at least 0.5 mg/dl during study; Cardiovascular diseases including heart failure, conductive disorders and MI; Hypokalemia during study; During Breast feeding; History of hypersensitivity to sulfonamides, sulfunilurea, carbonic anhydrase inhibitors and thiazides; Using cross-reacting medications like Heart Glycosides, Cisplatin, Glucocorticoids, Cyclosporine, ACE Inhibitors, Aminoglycosides, Beta2 Agonists, Allopurinol, Dofetilide, Probenecid, Risperidone, Sodium Phosphates and Topiramate.
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab eslami Street
City
Tehran
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
113353
Health conditions studied
1
Description of health condition studied
Neuropathic pain in spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Pain intensity
Timepoint
Time0, Month4, Month8
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Administrating oral 1 mg bumetanide tablets, BID, for 4 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Spinal Cord Injury Research Center
Full name of responsible person
Dr Hadjighaddem
Street address
Emam Khomeini Hospital, Keshavarz Bulvard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Brain and Spinal Cord Injury Research Center
Full name of responsible person
Dr Hadjighassem
Street address
Emam Khomeini Hospital, Keshavarz bulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Brain and Spinal Cord Injury Research Center
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
Brain and Spinal Cord Injury Research Center
Full name of responsible person
Dr Hadjighassem
Position
M.D, PhD in Neuroscience, PostDoctoral Fellow in Cellular and Molecular Neuroscience/ Assistant Prof
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Keshavarz bulvard
City
Tehran
Postal code
Phone
+98 21 6643 8635
Fax
Email
mhaji63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Brain and Spinal Cord Injury Research Center
Full name of responsible person
Dr Hadjighassem
Position
M.D, PhD in Neuroscience, PostDoctoral Fellow in Cellular and Molecular Neuroscience/ Assistant Prof
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Keshavarz Bulvard
City
Tehran
Postal code
Phone
+98 21 6643 8635
Fax
Email
mhaji63@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Advanced Technologies in Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Ebrahim Behzad
Position
M.D, PhD student in neuroscience
Other areas of specialty/work
Street address
No88, Italia St
City
Tehran
Postal code
Phone
+98 21 8899 1118
Fax
Email
ibrahimbehzad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)