| CTRI Number |
CTRI/2023/10/058420 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to demonstrate the effect of topical anesthetics Lidocaine and Prilocaine cream in subject undergoing cannulation for blood investigation. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo-Controlled, 3 Way Cross-Over Study to Demonstrate the Therapeutic Non-Inferiority of Lidocaine 2.5% and Prilocaine 2.5% Cream (Test Product) to Reference Product EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) Cream in Male and Female Subjects Undergoing Forearm Cannulation. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECTS/23/001, Version 00, Date: 03 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT 380015 India
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT 380015 India
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
CEO |
| Affiliation |
Ethicare Clinical Trial Service |
| Address |
Titanium City Centre, Block "G" 410-412, Nr. Sachin Tower, 100 Ft.Road, Satellite. Ahmadabad GUJARAT 380015 India
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| Gracure Pharmaceuticals Ltd.
251-254, 2nd Floor,
DLF Tower Block- IV,
15, Shivaji Marg, Delhi- 110015, India. |
|
|
Primary Sponsor
|
| Name |
Gracure Pharmaceuticals Ltd. |
| Address |
251-254, 2nd Floor,
DLF Tower Block- IV,
15, Shivaji Marg, Delhi- 110015, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Pragati Trivedi |
Prajna Healthcare Center |
205-208/2nd floor, Aagam Avenue,
Nr. Adani CNG pump, Sabarmati,
Ahmedabad – 380005, India
Ahmadabad
GUJARAT |
9265472125
phc.clinicaltrials@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medical Nursing Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) Cream |
A thick layer 2 g of cream which is approximately half of 5 g tube should be applied to the skin without rubbing, under an occlusive dressing to both forearms (dorsum hand) for a period of 2 hours on each period. |
| Intervention |
Lidocaine 2.5% and Prilocaine 2.5% Cream |
A thick layer of 2 g cream which is approximately half of 5 g tube should be applied to the skin without rubbing, under an occlusive dressing to both forearms (dorsum hand) for a period of 2 hours on each period. |
| Comparator Agent |
Placebo cream |
A thick layer 2 g of cream which is approximately half of 5 g tube should be applied to the skin without rubbing, under an occlusive dressing to both forearms (dorsum hand) for a period of 2 hours on each period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female between 18 to 65 years of age (both inclusive).
2. Subject who found peripheral venous cannulation painful (define as a pain recording of 25mm or greater on a 100 mm VAS for pain) without local anaesthetic.
3. The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
4. Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Subject with mental illness.
2.Known allergy or sensitivity to local anesthetics or hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients.
3.Damaged or inflamed skin or open wounds at the designated application site.
4.Use of analgesics during the past 24 hours.
5.Participation in any other study during last 1 month.
6.Suspected lack of compliance with any requirements of the study.
7.Any relevant abnormalities in the routine laboratory tests.
8.Smokers
9.Agitated or uncooperative subject.
10.Uncommunicative/deaf/mute subject.
11.Subject on hypnotics, or chronic pain relief medications.
12.Subject with hepatic impairment.
13.Subjects with atopic dermatitis
14.Subject who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lidocaine.
15.Subjects with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia.
16.Subjects treated with anti-arrhythmics of class III (e.g., amiodarone), methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital), medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers).
17.Subjects with Class I antiarrhythmic drugs (such as tocainide and mexiletine) which can have additive and potentially synergistic toxic effects.
18.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. |
|
|
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 |
| Change in pain score based on VAS score from baseline |
Day 1, Day 7, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Treatment Emergent Adverse events (TEAEs)
•Assessment of local tolerability (after 5 min & 30 min after cannula removal) |
Day 1, Day 7, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/11/2023 |
| Date of Study Completion (India) |
14/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to demonstrate the therapeutic non-inferiority of Lidocaine 2.5% and Prilocaine 2.5% cream (test product) to reference product EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) cream in subjects undergoing forearm cannulation. Sufficient number of subjects will be enrolled in the study to get 60 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit will be screening visit followed by randomization visit. Crossover visit will be on day 7 and day 14. Subjects will be screened for the eligibility criteria during screening visit. Subjects will be instructed to apply 2 g of cream approximately half of 5 g tube in a form of thick layer to the skin without rubbing, under an occlusive dressing to both forearms (dorsum hand) for a period of 2 hours for 14 days. Subjects will be randomized in three groups: test, reference and placebo. The primary endpoint will be change in pain score based on VAS score from baseline and the secondary end point will be treatment emergent adverse events and assessment of local tolerability (after 5 min and 30 min after cannula removal). |