| CTRI Number |
CTRI/2022/04/041691 [Registered on: 06/04/2022] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to evaluate the safety and efficacy of Fixed Dose Combination of Trypsin-Chymotrypsin, Aceclofenac and Paracetamol Tablets. |
|
Scientific Title of Study
|
“An Open Label, Prospective, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Trypsin – Chymotrypsin 150000 AU plus Aceclofenac 100 mg plus Paracetamol 325 mg Tablets in Patients for the treatment of acute inflammation and traumatic tissue pain.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/19/026, Version No.: 01 & Dated Nov 08, 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad-500072.
Hyderabad
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad-500072.
TELANGANA
500072
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Surender Kumar Arora |
| Designation |
President - Drug Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087.
New Delhi
DELHI
110087
India |
| Phone |
9811015684 |
| Fax |
|
| Email |
ska@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd. |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranab Kumar Chowdhury |
Down Town Hospital |
Research Room, Dispur, G.S. Road, Guwahati-781006.
Kamrup
ASSAM |
8486664152
pranabioc2002@gmail.com |
| Dr Bhanoth Valya |
Gandhi Medical College and Hospital |
Department of Orthopedics, Ground Floor, In Patient Block, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA |
9000357799
orthovalya@gmail.com |
| Dr K Sanjeev Kumar |
Government Medical College & Government General Hospital (Old RIMSGGH) |
Department of Orthopedics, Srikakulam-532001.
Srikakulam
ANDHRA PRADESH |
8942279033
drsanjeevkumarkare@yahoo.com |
| Dr Chandan Kumar |
GSVM Medical College |
Department of Orthopedics, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
9335313138
ck_80@rediffmail.com |
| Dr Vikalp Vashishitha |
Maharaja Agrasen Superspeciality Hospital |
Research Room, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN |
9829113330
vikalpvashishtha@gmail.com |
| Dr Asish Mondal |
Medical College and Hospital, Kolkata |
Department of Medicine, MCH Building, 4th Floor, 88 College Street, Kolkata-700073.
Kolkata
WEST BENGAL |
9232467518
drasish84@gmail.com |
| Dr Dattaraj K Nasnolkar |
Redkar Hospital and Research Centre |
Research Room, Mumbai-Goa Highway, Oshalbag, Village-Dhargal, Tal-Pernem, Goa-403513.
North Goa
GOA |
9158592177
redkar.research@gmail.com |
| Dr Rajesh Kumar |
W Pratiksha Hospital |
Research Room, Golf Course Ext. Road, Sushant Lok II, Sector 56, Gurugram-122011.
Gurgaon
HARYANA |
9810289056
clinsresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Submittted/Under Review |
| Ethics Committee, GSVM Medical College |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research, Medical College and Hospital |
Approved |
| Institutional Ethics Committee, Gandhi Medical College / Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH) |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital |
Approved |
| North East Healthcare Private Limited, W Pratiksha Hospital |
Approved |
| Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Trypsin - Chymotrypsin 150000 AU plus Aceclofenac 100 mg plus Paracetamol 325 mg Tablets |
Patients will be advised to take the study medication orally, swallowed as a whole with water twice daily for 10 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 to 65 years (both inclusive).
2. Patients with acute painful traumatic condition of orthopaedics such as ankle sprain.
3. Patients with pain at baseline must be ≥ 30 mm on a 0- 100 mm Visual Analogue Scale.
4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
2. Patients with clinical laboratory evaluations are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
3. Patients treated with Opioids & Corticosteroids within 1 week prior to the study.
4. Patients with chronic and degenerative conditions of pain.
5. Pregnant or lactating women.
6. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
7. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product.
8. Patients with clinically significant impaired renal or hepatic function [SGOT & SGPT more than 2.5X the UNL].
9. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
10. Patients with known case of Type 1 Diabetes and Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8%.
11. Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding.
12. Non-compliant with the study medication or any study related procedures.
13. Patients who have participated in any clinical trial in the past 3 months.
14. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication. |
Throughout the Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Visual Analog Scale (VAS) from baseline to end of the study. |
At Visit 1 / Day 1,
Visit 2 / Day 3,
Visit 3 / Day 7 and
Visit 4 / Day 10 |
| Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study. |
At Visit 1 / Day 1 and
Visit 4 / Day 10 |
| Changes in the ankle swelling & redness from baseline to end of the study. |
At Visit 1 / Day 1,
Visit 2 / Day 3,
Visit 3 / Day 7 and
Visit 4 / Day 10 |
| Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study. |
At Visit 4 / Day 10 |
| Changes in Laboratory Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study. |
At Visit 1 / Day 1 and
Visit 4 / Day 10 |
| Changes in Vital Signs from baseline to end of the study. |
At Visit 1 / Day 1,
Visit 2 / Day 3,
Visit 3 / Day 7 and
Visit 4 / Day 10 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "205"
Final Enrollment numbers achieved (India)="205" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
12/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
trial is an open label, prospective, non-comparative, multicentric, phase IV
clinical study to evaluate the safety, tolerability and efficacy of FDC of
Trypsin - Chymotrypsin 150000 AU + Aceclofenac 100 mg + Paracetamol 325 mg
Tablets in patients for the treatment of acute inflammation and traumatic
tissue pain.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening or baseline visit / Enrollment
visit (Visit 1). During this screening period, patients who are willing to give
consent will be evaluated for all the eligibility criteria. Eligible patients with
acute painful traumatic condition of orthopaedics such as ankle sprain and who
are aged 18 to 65 years of age (both inclusive) will be considered for the study.
After confirming the
inclusion/exclusion criteria the subject will be enrolled and provided with study
medication at enrollment visit. Patients will be provided with patient diary at
enrollment visit, which need to be brought along with in each subsequent visit
till the last visit. Follow up visits will be done on day 3±1, day 7±1 and day
10±1 (Final Visit) of treatment to assess safety, tolerability and efficacy. |