Comparison the efficacy of Duloxetine versus Gabapantin in patients with painful diabetic peripheral neuropathy
Design
This clinical trial study includes two groups of control and intervention with double-blind parallel groups, randomized using four-block method. The trail phase is 3.
Settings and conduct
A total of 104 patients admitted to the neurology clinic of Ahwaz Golestan Hospital with diagnosis of diabetic peripheral neuropathic pain (DPNP) and meet the inclusion criteria of study are randomly divided into A and B groups (each containing 52 subjects) using four-block method. Control or A group receives gabapentin and intervention B group receives duloxetine. Group A receives 300 mg oral gabapentin daily, and if the patients tolerate, dose increase by 300 for three days and reach to maximum dose of 900 mg daily. The group B receives 30 mg oral duloxetine daily, and if patients tolerate, dose increase to 60 mg daily after one week. Duration of treatment in both groups is 8 weeks. The pain level is assessed by visual analogue scale (VAS) before the start of medicine therapy and at the end of week 1, 4 and 8 and sleep interference score clinical global impression of change (secondary effect) are measured. Patients are evaluated by a researcher who has no information on patients treatment group. Both medicines are uniform in terms of appearance and provide for interviewer in pockets labeled A and B (each pocket contained adequate number of medicines for research period).
Participants/Inclusion and exclusion criteria
Patients referring to Neurology clinic of Golestan Hospital of Ahwaz with diagnosis of painful neuropathic diabetes (DPNP)
Intervention groups
Control group receive gabapentin and the intervention group receive duloxetine (DLX)
Main outcome variables
visual analogue scale (VAS) for pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161023030455N2
Registration date:2018-08-06, 1397/05/15
Registration timing:retrospective
Last update:2018-08-06, 1397/05/15
Update count:0
Registration date
2018-08-06, 1397/05/15
Registrant information
Name
Hosein Kaveiani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3989
Email address
kavyani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr. ABIDI pharmaceutical laboratory company and Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Duloxetine versus Gabapantin in patients with painful diabetic peripheral neuropathy
Public title
Comparative efficacy of Duloxetine versus Gabapantin in patients with painful diabetic peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged>18
rule out other DDx. for peripheral neuropathy
do nt use drug for treatment of DPNP
duration of diabetes ranging from 1 to 15 years
HbA1C less than 10 mg
A pain score of at least 40 mm on the 100 mm visual analogue scale (VAS)
Exclusion criteria:
patients who were already on other medication for the treatment of DPNP one week prior to the study enrolment
hepatic failure;
;renal failure with GFR<30 ml/min
concurernt of psycologic disoeder
cardiac arhythmia
patients with established neuropathy due to other causes;,
history of epilepsy
drug abuse
uncontoroled acute close angle Glocoma
recent MI
patients who did not give written informed consent
pregnant or lactating women
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Four block
Blinding (investigator's opinion)
Double blinded
Blinding description
First, medicines are uniformed by a physician who is not involved in data collection or analysis. Then, these medicines are provided for researcher as medicines A and B. The complications of both medicines are explained for each of them. They are informed that they can receive any of the medications randomly and written consent is taken from them. Then, medicines are given randomly to patients by one who is responsible for data collection. Another person analyzes the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences Department of Neurology
Street address
Ahvaz Jundishapur University of Medical Sciences Department of Neurology, Golestan st.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2016-05-27, 1395/03/07
Ethics committee reference number
IR.AJUMS.REC.1395.78
Health conditions studied
1
Description of health condition studied
painful diabetic peripheral neuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
pain
Timepoint
Before treatment and 1,4 and 8 weeks after treatment
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before treatment and 1,4 and 8 weeks after treatment
Method of measurement
Sleep interference score
2
Description
Changes in clinical status
Timepoint
1,4and 8 weeks after treatment
Method of measurement
Clinical Global Impression of Change
Intervention groups
1
Description
The gabapentin group receives the gabapentin at a dose of 300 mg per day. Then, the dose of 300 mg increases every three days to reach 900 mg per day (300 mg three times per day) and treatment continues for up to 8 weeks.
Category
Treatment - Drugs
2
Description
Duloxetine (DLX) group: this group receives Duloxetine at dose of 30 mg per day before bedtime, and after one week, it increases to 60 mg per day if patient tolerates, and treatment continues for up to 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurologic clinic of Golestan hospital
Full name of responsible person
Hosein Kaveiani
Street address
Golestan. Golestan hospital, Neurologic clinic
City
َAhvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 66 4250 3340
Fax
+98 66 4250 3340
Email
drkaveiani@gmail.com
Web page address
http://www.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences Department of Neuro
Full name of responsible person
Hosein Kaveiani
Street address
Ahvaz Jundishapur University of Medical Sciences Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 66 4250 3340
Fax
+98 66 4250 3340
Email
drkaveiani@gmail.com
Web page address
http://www.ajums.ac.ir
Grant name
پژوهشی
Grant code / Reference number
Research
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences Department of Neuro
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
Ahvaz University of Medical Sciences
Full name of responsible person
Hosein Kaveiani
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahvaz Jundishapur University of Medical Sciences Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 66 4250 3340
Fax
+98 66 4250 3340
Email
drkaveiani@gmail.com
Web page address
http://www.ajums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences Department of Neurology
Full name of responsible person
Hosein Kaveiani
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Ahvaz Jundishapur University of Medical Sciences Department of Neurology
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 66 4250 3340
Fax
+98 66 4250 3340
Email
drkaveiani@gmail.com
Web page address
http://www.ajums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hosein Kaveiani
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Street address
ajums
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 66 4250 3340
Fax
+98 66 4250 3340
Email
drkaveiani@gmail.com
Web page address
http://www.ajums.ac.ir/
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