| CTRI Number |
CTRI/2017/03/008263 [Registered on: 30/03/2017] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| 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 heparin sodium topical solution in
prevention of infusion associated phlebitis. |
|
Scientific Title of Study
|
A prospective, randomized, double blind, placebo controlled, parallel
group, multicenter, clinical study to evaluate safety and efficacy of
Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml in
prevention of infusion associated phlebitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/13/03/15, Version 1 dated 21-DEC-2015 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Amarinder Singh |
| Designation |
GM-Medical Services |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad , GUJARAT 380054
India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9099905926 |
| Fax |
|
| Email |
amarindersingh@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Amarinder Singh |
| Designation |
GM-Medical Services |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad , GUJARAT 380054
India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9099905926 |
| Fax |
|
| Email |
amarindersingh@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Amarinder Singh |
| Designation |
GM-Medical Services |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited,Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad , GUJARAT 380054
India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9099905926 |
| Fax |
|
| Email |
amarindersingh@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Limited, Commerce House-1’, Satya Marg,
Bodakdev, Ahmedabad -380054, Gujarat
(O) 079-26856242/43/44/45 |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House 1, Opp.Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad 380054, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Major R S Rengan |
Apollo First Med Hospitals |
no:154, P.H Road, Chennai-600010
Chennai
TAMIL NADU |
9841142294
dr.rsrengan@gmail.com |
| Dr Saurabh Misra |
Apollo Hospitals, Bangalore |
Minimal Access and Beriatric Surgery,
154/11, Bannerghatta Road, Opposite IIM, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA |
9972200999
drsaurabhmisra@gmail.com |
| Dr Rajeev M Joshi |
B Y L Nair Hospital |
Department of Surgery,
Dr. A. L Nair Road, Mumbai Central, Mumbai-400008
Mumbai
MAHARASHTRA |
9820540565
rajeevjoshi@gmail.com |
| Dr NK Chaudhary |
Christian Medical College and Hospital, Ludhiana |
Department of Surgery, CMC Hospital, Ludhiana, 141008, Punjab
Ludhiana
PUNJAB |
9216030600
nkchaudhry@gmail.com |
| Dr Pankaj Sihag |
Fortis Hospital, Ludhiana |
Fortis Hospital, Mundian Khurd, Chandigarh Road, Ludhiana (Punjab)-141015, INDIA
Ludhiana
PUNJAB |
8427255277
pankaj.sihag@fortishealthcare.com |
| Dr Soumen Das |
IPGMER & SSKM, Kolkata |
Department of Surgery,
244, Acharya Jagadish Chandra Bose Road,
Kolkata-700020, West Bengal
Kolkata
WEST BENGAL |
9830282494
soumendoc.das@gmail.com |
| Dr Hitesh Andhariya |
Sheth VS general Hospital |
Department of General Surgery,
Main Building,
Near Town Hall,
Ellisbridge,
Ahmedabad-380006
Ahmadabad
GUJARAT |
9825466766
drhiteshandharia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| IECCS of Apollo Hospitals, Bangalore |
Approved |
| Institutional Ethics Committee (IEC) Christian Medical College and Hospital, Ludhiana |
Approved |
| Institutional Ethics Committee of Topiwala National Medical College and BYL Nair Charitable Hospital |
Approved |
| Institutional Ethics Committee, Fortis Hospital, Ludhiana |
Approved |
| Institutional Ethics Committee, Smt. NHL Municipal Medical College Ahmedabad (NHLIEC) |
Approved |
| Institutional Ethics Committee-Clinical Studies, Apollo Hospitals, Chennai. |
Approved |
| IPGME&R Research Oversight Committee (Institutional Ethics Committee for research involving human subjects) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing cannulation of peripheral
vein that has been planned to remain in situ for at least 72 hours of indoor period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Matching placebo (topical solution without heparin sodium) |
6 to 8 drops of solution applied on skin over the cannulated vein approximately every 8 (±1) hours for the treatment period of 72 hours (total 9 doses) starting soon after (within 1 hour) cannulation |
| Intervention |
Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml |
Each ml (approximately 34 drops) of topical solution contains 1000 IU
equivalent heparin sodium.6 to 8 drops of solution applied on skin
over the cannulated vein approximately every 8 (±1) hours for the
treatment period of 72 hours (total 9 doses) starting soon after (within 1
hour) cannulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Either gender, age 18 to 65 years, both inclusive
2.Undergoing peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period
3.Willing & able to comply with study requirements, e.g. regular application of IP and efficacy-safety evaluation schedule, as
indicated by written informed consent provided by the patient.
4.If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing
to maintain reliable birth control throughout the study. |
|
| ExclusionCriteria |
| Details |
1.Undergoing re-cannulation due to phlebitis at earlier cannulation site
2.Unconscious or comatose patients
3.History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia
4.Planned administration of any of the following during study period:
ï‚· Anti-coagulants locally (at IV site or in the cannula) or
systemically
ï‚· NSAIDs locally at IV site
5.Patients having participated in any clinical trial within last 30 days at the time of screening
6.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of infusion phlebitis (grade II & above) during 72 hours of
treatment period |
[every 8±1 hours for 72 hours starting
within 1 hour of cannulation, total 10 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean time to develop infusion phlebitis (grade II or above) in hours.
For patients not reaching grade II by 72 hours, it will be 72 hours.
2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours
of treatment period.
3. Incidence of first signs of phlebitis (grade I)
4. Mean time to develop infusion phlebitis grade I (or above) in hours |
[every 8±1 hours for 72 hours starting
within 1 hour of cannulation, total 10 times]: |
|
|
Target Sample Size
|
Total Sample Size="374"
Sample Size from India="374"
Final Enrollment numbers achieved (Total)= "374"
Final Enrollment numbers achieved (India)="374" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2017 |
| Date of Study Completion (India) |
03/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of the trials will be published after completion of the trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective, randomized, double blind, placebo controlled, parallel group, multicenter, clinical study to evaluate safety and efficacy of Phlebotroy QPS (heparin sodium topical solution) 1000 IU/ ml in prevention of infusion associated phlebitis. Primary efficacy end point: Both treatments will be compared forï‚· Incidence of infusion phlebitis (grade II & above) during 72 hours of treatment period Secondary efficacy end points: Both treatments will be compared for 1. Mean time to develop infusion phlebitis (grade II or above) in hours. For patients not reaching grade II by 72 hours, it will be 72 hours. 2. Mean maximum intensity of pain experienced by patients at IV site recorded on 100 mm Visual Analogue Scale (VAS) during 72 hours of treatment period. 3. Incidence of first signs of phlebitis (grade I) 4. Mean time to develop infusion phlebitis grade I (or above) in hours Safety endpoints: ï‚· Incidence of treatment emergent (probably or certainly associated with study treatment as per WHO causality assessment) application site reactions. |