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CTRI Number  CTRI/2023/07/055428 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 13/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Phase IV]  
Study Design  Single Arm Study 
Public Title of Study   This Clinical Study will be conducted to Evaluate the Safety & Effectiveness of Triamcinolone Hexacetonide Injectable Suspension 20 mg/ml in Symptomatic Treatment of Subacute or Chronic Joint Inflammation in Indian Patients 
Scientific Title of Study   An Open-label, Single-arm, Multi-centric Phase IV Clinical Study to Evaluate the Safety & Effectiveness of Triamcinolone Hexacetonide Injectable Suspension 20 mg/ml in Symptomatic Treatment of Subacute or Chronic Joint Inflammation in Indian Patients 
Trial Acronym  NA 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
TRIA-422-0200 Ver 4.0 dated 14 Dec 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saurabh SHah 
Designation  Investigator 
Affiliation  Aartham Multispeciality Hospital 
Address  Aartham Multispeciality Hospital, Opp. Government Polytechnic, L-Colony, Near Panjarapoe Cross Road, Ambawadi, Ahmedabad

Ahmadabad
GUJARAT
380006
India 
Phone  9825243947  
Fax    
Email  drsnshah_13@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Kartik Peethambran 
Designation  Director Medical Affairs 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  9920072700  
Fax    
Email  kartik.peethambaran@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Acharya 
Designation  Associate Director Clinical Development & Operations 
Affiliation  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Private Limited Floor 17-18 Godrej BKC Plot No C 68 BKC Near MCA Club, Bandra (E), Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  8657552543  
Fax    
Email  shivani.acharya@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051  
 
Primary Sponsor  
Name  Abbott Healthcare Private Limited 
Address  Abbott Healthcare Pvt. Ltd Floor 16, Godrej BKC, Plot No. C-68, BKC, NearMCA Club, Bandra (E), Mumbai – 400051. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 Saurabh Shah  Aartham Multispeciality Hospital  Aartham Multispeciality Hospital, Opp. Government Polytechnic, L-Colony, Near Panjarapoe Cross Road, Ambawadi, Ahmedabad
Ahmadabad
GUJARAT 		 9825243947

drsnshah_13@yahoo.co.in 
Dr KP Raju  BGS Global Institute of Medical Sciences  BGS Global Institute of Medical Sciences Uttaranalli Main RoadKEngeri, Bangalore- 560060, Karnataka
Bangalore
KARNATAKA 		 9480289496

rajukp72@gmail.com 
Dr Kaushal Anand  GMERS medical college & civil hospital   GMERS medical college & civil hospital Sola, Orthopedic department, Ground floor, OPD building sola civil, Sarkhej-Gandhinagar High way, Sola, Ahmedabad-380060, Gujarat
Ahmadabad
GUJARAT 		 9909013564

kaushal87anand@gmail.com 
Dr K Sanjeev Kumar  Government medical college & Government general hospital  Research Wing, 2nd floor, behind FM Ward, Government medical college & Government general hospital, Srikakulum-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH 		 8942279033

drsanjeevkumarkare@yahoo.com 
Dr Rohit Nath   GSVM Medical college  GSVM Medical college, Swaroop Nagar, Kanpur-208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 		 8009984093

nath.ortho@gmail.com 
Dr Kaushik Basu  Medical College Kolkata  Medical College Kolkata, 88, College St, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL 		 9038831211

phoenix.0013@gmail.com 
Dr P Suryanarayan  SRM Hospital  SRM Institutes for medical science, No. 1, Jawaharlal Nehru Salai, Vadapalani, Chennai - 600026
Chennai
TAMIL NADU 		 9841043945

pichai.suryanarayan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Aartham EC  Approved 
Ethics Committee GSVM Medical College  Approved 
IEC Government medical college and Government General Hospital  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee for human research   Approved 
Institutional Ethics Committtee GMERS  Approved 
SRM Institutes for Medical Science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M254||Effusion of joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Triamcinolone Hexacetonide  Injectable Suspension 20 mg/ml will be administered on day 0 i.e. on enrollment visit of the study intraarticularly/periarticular in the target joint. Patient will be further followed up till day 84+/-3 days.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  A patient must fulfill all the following criteria for inclusion in this study:
1. Adolescent and adult patients aged ≥ 13 years.
2. Patients with subacute and chronic inflammation of a joint requiring treatment with the use of intraarticular/intra-synovial/periarticularsteroids based on investigator’s discretion.
3. Patients with pain intensity with a VAS score ≥ 45 mm at screening and baseline.
4. Patients willing to comply with the study procedures and requirements
5. Patients/parents/legal guardians or representatives/caregivers who are able to read,understand, and are willing to sign and date the informed consent form.
6. Patients/parents/legal guardians or representatives/caregivers are willing to fill the
patient diary and comply with the study procedure and requirements 
 
ExclusionCriteria 
Details  A patient will not be included in the study if they meet any of the exclusion criteria listed
below:
1. Significant (requiring surgical correction) deformity of the target joint.
2. Concomitant inflammatory or any other disease/condition which may affect joints (e.g. metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
3. History of sepsis in the target joint or any clinical concern for acute or subacute infectious process in the target joint e.g. active tuberculosis, herpes simplex keratitis,systemic mycoses, and parasitoses (strongyloid infections).
4. Clinically apparent tense effusion at the target joint
5. Skin disease or infection in the area of the injection site.
6. Arthrocentesis in the past 3 months.
7. Allergic to the study drug or any of the other ingredients.
8. Participation in any other clinical study in the past 30 days.
9. Patients who had received intraarticular and/or periarticular systemic steroids in the previous 3 months.
10. Any contra-indication to intraarticular and/or periarticular injection.
11. Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating
12. Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigators discretion
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number & proportion of patients with treatment-emergent adverse events (TEAEs) from baseline to end of the study Week 12.  Baseline to weeks 1 4 8 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the effectiveness of THA 20 mg/ml from administration to end of the study i.e. 12 weeks. in terms of:
a. reduction in pain intensity
b. reduction in severity & duration (minutes) of stiffness
c. patient & investigator global assessment of disease activity
2. To evaluate the proportion of patients who take rescue medication tablets (Paracetamol 500 mg) for target local pain & mean number of rescue medication tablets (Paracetamol 500 mg) takenwhere THA was administered, from baselines to 12 th week i.e. end of the study.  		 Baseline to weeks 1 4 8 12 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/07/2023 
Date of Study Completion (India) 29/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Its An Open-label, Single-arm, Multi-centric Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Triamcinolone Hexacetonide Injectable Suspension 20 mg/ml in Symptomatic Treatment of Subacute or Chronic Joint Inflammation in approximately 200 Indian Patients from approximately 10 clinical sites. There are six visits in the study and study duration is of 336 days (48 weeks) 
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