| CTRI Number |
CTRI/2013/07/003838 [Registered on: 25/07/2013] Trial Registered Prospectively |
| Last Modified On: |
10/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU) |
|
Scientific Title of Study
|
An Interventional, Placebo-controlled, Randomized, Double blinded, Dose comparison, Phase I/II Study to determine the safety and efficacy of a new gel formulation of Esmolol Hydrochloride (GALNOBAX®) for the treatment of Diabetic Foot Ulcer (DFU) |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01113515 |
ClinicalTrials.gov |
| Novalead-Galnobax-0210,ProtocolVersion 7.2 dated 01-Nov-2012 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Partha Chatterjee |
| Designation |
Head - Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
Kalpataru Prime,
1st Floor, Unit Nos. 3 and 4,
Plot No. D-3, Road No. 16,
Wagle Industrial Estate,
Thane (West)
Thane
MAHARASHTRA
400604
India |
| Phone |
02261088000 |
| Fax |
|
| Email |
partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Partha Chatterjee |
| Designation |
Head - Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
Kalpataru Prime,
1st Floor, Unit Nos. 3 and 4,
Plot No. D-3, Road No. 16,
Wagle Industrial Estate,
Thane (West)
Thane
MAHARASHTRA
400604
India |
| Phone |
02261088000 |
| Fax |
|
| Email |
partha.chatterjee@siroclinpharm.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novalead Pharma Private Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Novalead Pharma Private Limited |
| Address |
Plot No.-05, Second Floor, Ram Indu Park,
Survey No.-131/1B/2/11, Baner Taluka Haveli,
Pune, Maharashtra- 411045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Novalead Pharma Pvt Ltd |
Plot No.-05, Third Floor, Ram Indu Park,
Survey No.-131/1B/2/11, Baner Taluka Haveli,
Pune, Maharashtra- 411045 |
| SIRO Clinpharm Pvt Ltd |
Kalpataru Prime,
1st Floor, Unit Nos. 3 and 4,
Plot No. D-3, Road No. 16,
Wagle Industrial Estate,
Thane (West) - 400604,
Maharashtra. |
|
|
Countries of Recruitment
|
India
Malaysia
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Deshmukh |
Deenanath Mangeshkar Hospital & Research Centre |
Erandwane
Pune
Pune
MAHARASHTRA |
02040151000
mandeshmukh@rediffmail.com |
| Dr Hemanga Barman |
M V Hospital for Diabetes Pvt. Ltd. |
No: 04, West Madha Church Street,
Royapuram,
Chennai-13
Chennai
TAMIL NADU |
04425954913
drbarmanh007@rediffmail.com |
| Dr Arun Bal |
S L Raheja Hospital |
Raheja Rugnalaya Marg
Mahim (W), Mumbai-400016, India
Mumbai
MAHARASHTRA |
02266529999
arunbal@vsnl.net |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee of M V Diabetes and Research Centre |
Approved |
| Institutional Ethics Committee, DMH & RC |
Approved |
| Institutional IRB S. L. Raheja Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Foot Ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Esmolol hydrochloride (Galnobax®) 14% |
14% gel twice daily to be applied topically for 12 weeks. In case the ulcer/wound heals prior to the mandatory 12-week period, the subject will enter the follow-up phase of the trial immediately |
| Intervention |
Esmolol hydrochloride (Galnobax®) 20% |
20% gel twice daily to be applied topically for 12 weeks. In case the ulcer/wound heals prior to the mandatory 12-week period, the subject will enter the follow-up phase of the trial immediately |
| Intervention |
Esmolol hydrochloride (Galnobax®) 20% and Placebo |
Each once daily for 12 weeks. In case the ulcer/wound heals prior to the mandatory 12-week period, the subject will enter the follow-up phase of the trial immediately |
| Comparator Agent |
Placebo |
Twice Daily to be applied topically for 12 weeks. In case the ulcer/wound heals prior to the mandatory 12-week period, the subject will enter the follow-up phase of the trial immediately. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having single or up to two ulcers, minimum 4.0 cm apart, below knee ulcer of at least 4 weeks and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
Ulcer should be clinically non-infected as determined by clinical examination and complete hemogram
Ulcer area (length x width) measurement between 1.5 square centimeter and 10 square centimeter, inclusive and post debridement ulcer area less than or equal to 12 square centimeter
Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner’s classification system |
|
| ExclusionCriteria |
| Details |
Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
Patients with target limb cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Efficacy endpoint:
Reduction in area and volume of ulcers
Safety endpoint:
Incidence of adverse events (AEs) |
Efficacy endpoint:
Week 12 from baseline / wound closure which ever is earlier
Safety endpoint:
nd of follow up phase |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy endpoint:
Time taken for healing and closure of wound in different groups
Pharmacokinetic (PK) endpoint:
Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU. |
Efficacy endpoint:
From baseline
Pharmacokinetic (PK)endpoint:
Drug concentration in blood on Day 0, Week 1, Week 4, Week 12 |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
20/02/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
20/02/2014 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Galnobax® is a new gel which potentiates the wound healing process by modulation of several impaired diabetic wound healing processes. The pre-clinical experiments indicates that Galnobax® enhances collagen turnover and deposition, induces nitric oxide, inhibits the cAMP pathway, reduces oxidative stress of the cells at the wound site. This study is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application upon time taken for the ulcer to heal and close will also be studied in the phase. The study will recruit 50 subjects of which 40 subjects competitively in India and Malaysia and 10 subjects in USA. Out of subjects recruited in India, 16 willing subjects will be considered for pharmacokinetic study of Galnobax. The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up. There are four groups in the trial: three treatment groups and one placebo control group.
The recruitment for the study is completed and the last patient was enrolled on 31-Jan-2015. |