| CTRI Number |
CTRI/2013/05/003646 [Registered on: 17/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/04/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of the efficacy and safety of Epalrestat to Pregabalin in patients suffering from painful diabetic peripheral neuropathy. |
|
Scientific Title of Study
|
A prospective, controlled, randomized, double blind, comparative, parallel, 2-arms study to evaluate the efficacy and safety of Epalrestat (150 mg) compared to Pregabalin (600 mg) in patients suffering from painful diabetic peripheral neuropathy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EP/PDN/12/2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Devendrarao Shende |
| Designation |
Resident Doctor |
| Affiliation |
Govt. Medical College Aurangabad. |
| Address |
Dept. of Pharmacology,
GMCH, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
09579016106 |
| Fax |
|
| Email |
sachindshende@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Devendrarao Shende |
| Designation |
Resident Doctor |
| Affiliation |
Govt. Medical College Aurangabad. |
| Address |
Dept. of Pharmacology,
GMCH, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
09579016106 |
| Fax |
|
| Email |
sachindshende@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Devendrarao Shende |
| Designation |
Resident Doctor |
| Affiliation |
Govt. Medical College Aurangabad. |
| Address |
Dept. of Pharmacology,
GMCH, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
09579016106 |
| Fax |
|
| Email |
sachindshende@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Investigator Initiated study |
| Address |
Dept. of Pharmacology
GMCH, Aurangabad |
| Type of Sponsor |
Other [Principle investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sachin Devendrarao Shende |
Govt. Medical College, Aurangabad |
Govt. Medical College, Panchakki road,Aurangabad,
431001.
Aurangabad
MAHARASHTRA |
09579016106
sachindshende@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt. Medical College, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Painful diabetic peripheral neuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epalrestat (150mg) |
Epalrestat (150mg)
:oral
:once daily for maximum period of 90 days
|
| Comparator Agent |
Pregabalin (600 mg) |
Pregabalin (600 mg)
:oral
:once daily for maximum period of 90 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group between 20 to 70 years.
2. Diabetic patients stabilized on antidiabetic medication (on stable dose of antidiabetic drugs for the last 4 weeks) with stable glycemic control (HbA1c < 9%, with ± 0.5% variation in the previous 3 months) presenting with subjective symptoms of peripheral neuropathy confirmed on the basis Modified neuropathy disability score >2.
3. Subjects whose pain score of at least 40 mm on the 100 mm visual analogue scale (VAS)
|
|
| ExclusionCriteria |
| Details |
1. Patients with stage 3 (N3) i.e. disabling neuropathy or presence of symptoms/ signs of foot ulcer.
2. Patients with diabetic neuropathy requiring hospital admission for management of neuropathy/ diabetic complications / any other disease condition.
3. Patients presenting with primary cause of neurologic disorders other than diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease).
4. Patients with history of or current diagnosis of mania, bipolar disorder, obsessive-compulsive disorder, or posttraumatic stress disorder or to be at risk of suicide judged before randomization.
5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.
6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
7. Patients with H/O alcohol/ drug abuse.
8. Pregnant and lactating females.
9. Simultaneous participation in another clinical study or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Primary Efficacy Parameters:
a.Pain severity as measured on 11 point Visual Analogue scale (VAS)
b.Modified neuropathy disability score |
Efficacy parameters- 0, 30 days, 60 days, 90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2)Secondary Efficacy Parameters:
a. Other symptom intensity will be assessed on VAS
b. Relief of Pain / any other symptom will be assessed on VAS
c. Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC) |
Efficacy parameters- 0, 30 days, 60 days, 90 days
|
Safety parameters:
1. ADR recording,
2. blood investigations |
Safety parameters- 0, 90 days. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/12/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prospective, controlled, randomized, double blind, Comparative, parallel, 2-arms study, evaluating and comparing the effects of oral Epalrestat (150mg) compared to Pregabalin (600 mg) in patients suffering from painful diabetic peripheral neuropathy. Patients will be divided into two groups; Group I patients will receive the investigational product Epalrestat (150mg) as oral therapy, Group II patients will Pregabalin (600 mg) orally. Efficacy parameters: 1) Primary: a. Pain severity as measured on 11 point Visual Analogue scale (VAS) b. Modified neuropathy disability score 2) Secondary: a. Other symptom intensity will be assessed on VAS b. Relief of Pain / any other symptom will be assessed on VAS c. Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change Assessment Schedule: Efficacy parameters- 0, 30 days, 60 days, 90 days Safety parameters- 0, 90 days. |