The comparison of duloxetine and pregabalin effects on plasma concentration of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) in type 2 diabetic patients and the role of these mediators in neuropathic pain
Objectives: The aims of this study are to compare the effects of Duloxetine and Pregabalin on plasma concentration of NO and iNOS in painful neuropathic patients with type 2 diabetes and to evaluate the relation of plasma concentration of No and iNos with patients neuropathic pain severity.
Design and setting: We will randomly select 60 patients with considering some inclusion and exclusion criteria and then we will divide them to two equal number groups. The study will be single blind. Plasma concentration of No and iNos will be compared before and after administration of Duloxetine and Pregabalin. Correlation between No and iNOS plasma concentration and neuropathic pain will also be evaluated.
Major eligibility criteria: Type 2 diabetic patients, 40-60 years old, both genders, having at least 4 score diabetic neuropathic pain by Visual Analogue Scale (VAS), having healthy liver and kidney performance and not having any other neuropathy
Interventions: one of groups will receive placebo of Duloxetine 30 mg capsules once daily and the other group will receive placebo of Pregabalin 75 mg capsules twice daily for ten days before drugs beginning, afterward, the first group will receive Duloxetine 30 mg once daily for one week and then 60 mg once daily for seven more weeks. The second group will receive Pregabalin 75 mg twice daily for one week, afterward, 150 mg twice daily for seven more weeks. we will collect patients blood samples before drugs administration and day 30 and day 60 after drugs taking.
Variables: Finally we will assay NO and iNOS concentration of blood samples by means of ELISA kits. We will evaluate pain severity of patients weekly by VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012932277N1
Registration date:2017-07-19, 1396/04/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-19, 1396/04/28
Registrant information
Name
Moosareza Memari
Name of organization / entity
Pharmacology Department, School of Medicine, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2539
Email address
reza_memari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The budget: Vice Chancellor for research affair of Shahid Beheshti University of
Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of duloxetine and pregabalin effects on plasma concentration of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) in type 2 diabetic patients and the role of these mediators in neuropathic pain
Public title
Identification of the probable mechanisms of Duloxetine and Pregabalin involving in treatment of neuropathic pain of type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Type 2 diabetic patients with neuropathic pain which have the pain score over 4 on Visual Analogue Scale (VAS) for more than 3 months; 2-The age range: 40-60 years; 3- The patients should fill out and sign the consent forms
Exclusion criteria:
1-Hypersensitivity to Duloxetine and Pregabalin; 2-Kidney or liver failure; 3-Any other neuropathies (spinal cord injury, discopathy, congenital neuropathy, vocational, hypothyroidism, collagen vascular disease, vasculitis, Paraneoplastic disorders, immunological, alcoholism and drugs induced); 4- Rheumatoid Arthritis; 5-Goat; 6-Epilepsy; 7-Orthopedic complications; 8- Vision disability; 9-Intellectual disorders; 10-Usage of analgesic and anti-inflammatory drugs; 11-Type 1 diabetes; 12-Hypertension; 13-Smoking
Age
From 39 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Koodakyar Avenue, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Postal code
1985717443
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
IR.SBMU.MSP.REC.1395.41
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
2
Description of health condition studied
Pain due to diabetic polyneuropathy
ICD-10 code
G63.2*
ICD-10 code description
Diabetic polyneuropathy
3
Description of health condition studied
Autonomic neuropathy
ICD-10 code
G99.0
ICD-10 code description
Autonomic neuropathy in endocrine and metabolic diseases
Primary outcomes
1
Description
Plasma concentration of Nitric Oxide Synthase
Timepoint
Before drug prescription and on days 30 and 60 after that
Method of measurement
ELISA kit
2
Description
Plasma concentration of Nitric oxide
Timepoint
Before drug prescription and on days 30 and 60 after that
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Pain
Timepoint
Before drugs prescription and every week after that
Method of measurement
Visual Analogue Scale (VAS)
2
Description
َAdverse drug reactions
Timepoint
Every day
Method of measurement
Interview with patients and their reports
Intervention groups
1
Description
Duloxetine group: Duloxetine 30 and 60 mg capsules, formulated by Sobhan pharmaceutical factory, Duloxetine 30 mg capsules will be prescribed once daily at first week, afterward, Duloxetine 60 mg capsules will be prescribed once daily for seven more weeks and before these eight weeks Duloxetine 30 mg placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed once daily for ten days
Category
Treatment - Drugs
2
Description
Pregabalin group: Pregabalin 75 and 150 mg capsules, formulated by Sobhan pharmaceutical factory, Pregabalin 75 mg capsules will be prescribed twice daily at first week, afterward, Pregabalin 150 mg capsules will be prescribed twice daily for seven more weeks and before these eight weeks Pregabalin 75 mg placebo capsules (manufactured by Sobhan pharmaceutical factory) will be prescribed twice daily for ten days