| CTRI Number |
CTRI/2013/02/003347 [Registered on: 05/02/2013] Trial Registered Prospectively |
| Last Modified On: |
29/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
A clinical trial to study the effects of GRC 17536 in patients with painful diabetic peripheral neuropathy (painful extremities due to peripheral nerve damage in diabetic patients). |
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Scientific Title of Study
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A Phase II, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GRC 17536-203; version no.1.0, dated:18.06.2012 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Venkateshan S P |
| Designation |
Sr Manager Clinical Sciences |
| Affiliation |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark Pharmaceuticals Ltd,
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane
MAHARASHTRA
400709
India |
| Phone |
912267720000 |
| Fax |
|
| Email |
venkateshans@glenmarkpharma.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Sachan |
| Designation |
Manager, Medical Writing |
| Affiliation |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark Pharmaceuticals Ltd,
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane
MAHARASHTRA
400709
India |
| Phone |
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| Fax |
|
| Email |
shailendrasachan@glenmarkpharma.com |
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Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals SA |
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Primary Sponsor
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| Name |
Glenmark Pharmaceuticals SA |
| Address |
Glenmark Pharmaceuticals SA,
Chernin de la Combeta, 5, 2300 La Chaux-de-fonds, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
Modification(s)
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Czech Republic
Germany
India
United Kingdom |
Sites of Study
Modification(s)
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| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arthur Asirvatham |
Arthur Asirvatham Hospital |
No 42-A, Kuruvikaran Salai,
Anna nagar So,Madurai - 625020
Madurai
TAMIL NADU |
09443751977
asirvath.cr@gmail.com |
| Dr Paramesh Shammana |
Bangalore Clinisearch |
No. 416, 4th Cross, 2nd Block,Kalyan Nagar, Bangalore-560043,Karnataka.
Bangalore
KARNATAKA |
09845010610
drparamesh2@gmail.com |
| Dr Jayashri Shembalkar |
Getwell Hospital and Research Centre |
Department of Endocrinology, 20/1, Dr. Khare Marg, Dhantoli, Nagpur
Nagpur
MAHARASHTRA |
09665013901
pkshembalkar@hotmail.com |
| Dr Mohan Magdum |
Jehangir Clinical Development Centre Pvt. Ltd. |
Jehangir Hospital Premises,
32 Sassoon Road,Pune - 411001
Pune
MAHARASHTRA |
09822217243
mohanmagdum@gmail.com |
| Dr S Srikanta |
Jnana Sanjeevani Medical Centre |
Diabetes Department, No.2, 1st A Cross,
Marenahalli,J.P Nagar Phase 2, Bangalore,
Bangalore
KARNATAKA |
09886042322
samatvam@gmail.com |
| Dr Mallikarjun V Jali |
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre |
Department of Medicine, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
09844032499
drmvjali@gmail.com |
| Dr Balamurugan Ramanathan |
Kovai Diabetes Speciality Centre and Hospital |
15, Vivekananda road, Ramnagar, Coimbatore
Coimbatore
TAMIL NADU |
09842244881
Balamurugan_dr@hotmail.com |
| Dr Dinesh Dhanwal |
Maulana Azad Medical College & Associate Hospitals |
Department of Medicine, Room No. 115, 1st Floor, B.L. Taneja Block, Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI |
09968604275
dineshdhanwal@hotmail.com |
| Dr Vijay Viswanathan |
MV Hospital for Diabetes (P) Ltd |
4, West Madha Church Street, Royapuram, Chennai
Chennai
TAMIL NADU |
09840055535
Vijayviswanathan92@gmail.com |
| Dr Sunil M Jain |
TOTALL Diabetes Hormone Institute, A unit of Hormone Research Institute Pvt. Ltd |
Diabetes Department, BCM Health Island, PU 4,
Scheme 54, Behind Prestige Management Institute, Near Bombay Hospital, Indore- 452010
Indore
MADHYA PRADESH |
09826023182
sunilmjain@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Arthur Asirvatham Hospital,Institutuonal Review Board, Madurai |
Approved |
| Bangalore Clinisearch Institutional review Board |
Submittted/Under Review |
| Ethics Commiittee of Diabetes Thyroid Hormone research Institute PVT. Ltd., Indore |
Approved |
| Ethics Commiittee of KLE university, KLE university, Belgam |
Approved |
| Ethics Committee of Prof. M Viswanathan Diabetes Research Centre, M.V.Hospital for Diabetes(P) Ltd, Chennai |
Approved |
| Getwell Institutional Ethics Committe, Nagpur |
Approved |
| Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital, Coimbtore |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College, New Delhi |
Approved |
| Jehangir Clinical Development Centre Institutional Reviw Board, Pune |
Approved |
| Science for Health, Jnana Sanjeevini Medical Centre, Bangalore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Painful Diabetic Peripheral Neuropathy , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GRC 17536 |
BID for 4 weeks, oral adminstration |
| Comparator Agent |
Matching Placebo |
BID for 4 weeks, oral adminstration |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to provide voluntary written informed consent
2. Male and female (women of non child-bearing potential) patients ≥18 yrs and ≤75 yrs
3. Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months
4. A baseline 24-hour average daily pain intensity score ≥5
5. Women must be of non child-bearing potential, defined as post menopausal or surgically sterile
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| ExclusionCriteria |
| Details |
1. Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
2. Other causes of neuropathy or lower extremity pain
3. Complex regional pain syndrome or trigeminal neuralgia
4. Lower extremity amputations other than toes
5. Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study
6. Major depression.
7. Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
8. Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigators medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patients safety or study outcome
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Mean 24-hour average pain intensity (API) score |
Time Frame: 4 weeks
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Mean night-time API Score |
Time Frame: 4 weeks |
| Patient Global Impression of Change |
Time Frame: 4 weeks |
| Clinician Global Impression of Change |
Time Frame: 4 weeks |
|
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Target Sample Size
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Total Sample Size="138"
Sample Size from India="83"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
|
07/02/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
17/12/2012 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
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Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN.
The study will be conducted in 10 centres in India, and 1 each, in Germany and the UK. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity. |