| CTRI Number |
CTRI/2022/01/039531 [Registered on: 18/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) / Paracetamol (325 mg) / Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery |
|
Scientific Title of Study
|
A prospective, randomized, open-label, two-arm, active-controlled, parallel, multicentre, post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) as compared to FDC of Aceclofenac (100 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FDC_01 Version 00 Dated 08/DEC/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshan Pawar |
| Designation |
Senior Manager, Medical |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9819677607 |
| Fax |
|
| Email |
roshan.pawar@alkem.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshan Pawar |
| Designation |
Senior Manager, Medical |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,
Lower Parel
Mumbai
MAHARASHTRA
40013
India |
| Phone |
9819677607 |
| Fax |
|
| Email |
roshan.pawar@alkem.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshan Pawar |
| Designation |
Senior Manager, Medical |
| Affiliation |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg,
Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
9819677607 |
| Fax |
|
| Email |
roshan.pawar@alkem.com |
|
|
Source of Monetary or Material Support
|
| Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg, Lower Parel Mumbai MAHARASHTRA 400013 |
|
|
Primary Sponsor
|
| Name |
Alkem Laboratories Limited |
| Address |
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg, Lower Parel Mumbai MAHARASHTRA 400013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Mehta |
Dr. Ritus Dental Clinic |
OPD Room, Shop No. 10, Suryamandir Tower, Near Sambhav Press, off Judges Bunglow, Bodakdev,
Ahmadabad
GUJARAT |
7600650300
info@drritudentalclinic.com |
| Dr Swati Makhija |
Makhija Dental Clinic |
Room 1, E-300, SobO Centre, South Bopal
Ahmadabad
GUJARAT |
8980568746
drswatimakhija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aceclofenac (100 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) |
Twice daily orally for 5 days |
| Intervention |
FDC of Diclofenac (50 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) |
Twice daily orally for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female patients of age 18-45 years (both inclusive).
2. Patients needing extraction for impacted third molars under local anaesthesia.
3. Patients having moderate to severe pain at baseline (once surgery is over and local anaesthetic effect has subsided).
4. Patients in general good health- American Society of Anaesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of outpatient conscious sedation).
5. Patients willing to give written informed consent and comply with the study procedure |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to any of the study drugs.
2. Patients with any contraindication to the study drugs.
3. Patients who are pregnant or nursing.
4. Patients with history of peptic ulcers and/or GI bleeding.
5. Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery).
6. Patients developing any complication during or after surgery. Unusual surgical difficulty.
7. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 8. Patients with continuing history of alcohol and/or drug abuse. 9. Participation in another clinical trial in the past 1 month prior to screening. 10. Any other reason for which the investigator feels that patient should not participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sum of pain intensity difference in 6 hours (SPID6) |
Sum of pain intensity difference in 6 hours (SPID6) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total pain relief in 6 hours (TOTPAR6)
2. Time to onset of analgesia
3. Time to Maximum pain relief (tMaxPR)
4. Pain relief at 48 and 96 hours (PR48 and PR96)
5. Change in swelling from baseline to end of the study
6. Requirement of rescue analgesia during the study period
7. Overall efficacy at end of study |
6 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 trial is a prospective, randomized, open-label, two-arm, active-controlled, parallel, multicentre, post marketing clinical trial to assess the efficacy and safety of Enzoflam Tablet as compared to Zerodol-SP Tablet in patients with postoperative dental pain after third molar surgery. All the patients being prescribed the medication will be enrolled in the study. As this is a post marketing clinical trial to evaluate the efficacy and safety of the drug, free samples will be given to all the patients to ensure that the patients do not change the test product being used. After the third molar surgery, patients will be evaluated for all the eligibility criteria. Eligible patients will be administered with study medication & patient dairy card. Additionally, patients will be given rescue medication (Tramadol Tablets) which they will be allowed to take if they have unbearable pain even 2 hours after taking the study medication. Patients will be instructed to take study medication one tablet twice daily (one in the morning and one in the evening). Also, patients will be trained on patient diary card to note down the pain intensity at various time points, dosage details such as date, time, dose, frequency of administration or missed dose. These details will be used to assess the treatment compliance. |