| CTRI Number |
CTRI/2024/01/061844 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess efficacy and safety of Febuxostat ER Tablet versus Febuxostat IR Tablet |
|
Scientific Title of Study
|
A Prospective, Randomized, Open-labelled, Multi-centric, Parallel-group, Phase III Study to Assess the Efficacy and Safety of Febuxostat ER Tablet 40/80 mg versus Febuxostat IR Tablet 40/80 mg for treatment of chronic hyperuricemia in conditions where urate depression has already occurred (including a history, or presence of tophus and /or gouty arthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VRL-CT-23-007 Version 1.0 Date 16.02.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigar Modia |
| Designation |
Principal Investigator |
| Affiliation |
Jupiter Hospital and Research Centre |
| Address |
Jupiter Hospital and Research Department of Medicine First floor OPD 1 Centre opposite ICAI Bhavan Sunpharma Atladra Road Vadodara
Vadodara
GUJARAT
390012
India |
| Phone |
9913041639 |
| Fax |
|
| Email |
drjigarmodianm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigar Modia |
| Designation |
Principal Investigator |
| Affiliation |
Jupiter Hospital and Research Centre |
| Address |
Jupiter Hosital and Research Department of Medicine First floor OPD 1 Centre opposite ICAI Bhavan Sunpharma Atladra Road Vadodara
Vadodara
GUJARAT
390012
India |
| Phone |
9913041639 |
| Fax |
|
| Email |
drjigarmodianm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Badrinath Sangle |
| Designation |
Director |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Clinical Trial Department First Floor Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Clinical Trial Department First Floor Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9930646601 |
| Fax |
|
| Email |
badrinath@vivotechresearch.com |
|
|
Source of Monetary or Material Support
|
| AKUMS DRUGS & PHARMACEUTICALS LTD
First floor CT Dept Plot No 131 to 133 Block C Mangolpuri Industrial Area Phase I Adjoining CBSE Office
Delhi 110083 India |
|
|
Primary Sponsor
|
| Name |
AKUMS DRUGS PHARMACEUTICALS LTD |
| Address |
First floor CT Dept Plot No 131 to 133 Block C Mangolpuri Industrial Area Phase I adjoining CBSE Office
Delhi 110083 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bishnu Prasad Patro |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, Dept. of Orthopedics, First floor. Sijua, Patrapada, Bhubaneswar-751019, Odisha, India
Khordha
ORISSA |
07437182313
bishnucolours@gmail.com |
| Dr Girish Sonwalkar |
Belagavi Institute of Medical Sciences |
Department of Orthopedics, Ground Floor, Dr. BR Ambedkar Road, Sadashiv Nagar, Belgavi 590010
Belgaum
KARNATAKA |
09448144615
drgirishsonwalkar@gmail.com |
| Dr Utkarsha Patil |
Bhate Hospital |
Bhate Hospital, Clinical trial dept, Ground floor, Dr Ambedkar Road, opp. Civil Hospital, Belgavi - 59002
Belgaum
KARNATAKA |
09035774218
utkarsha_narone@yahoo.com |
| Dr Digvijay Agarwal |
Himalayan Institute of Medical Sciences |
Department of Orthopedics, Ground floor, Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand, India- 248016
Dehradun
UTTARANCHAL |
07579060588
agarwaldigvijay5@gmail.com |
| Dr Jigar Modia |
Jupiter Hospital |
Jupiter Hosital and Research Department of Medicine First floor OPD 1 Centre opposite ICAI Bhavan Sunpharma Atladra Road Vadodara
Vadodara
GUJARAT |
9913041639
drjigarmodianm@gmail.com |
| Dr Rishi Doshi |
Kolhapur Institute of Orthopedics and Trauma |
Dept of Ortho, 204 Kh, Near CBS, New Shahupuri ,Kolhapur
Kolhapur
MAHARASHTRA |
9921698080
drrishidoshi@kiothospital.org |
| Dr Muddapu Pardhasaradhi |
Medigene Multispecialty Hospital Private Limited |
Dept of Ortho, D.No.43-9-201, Sy No. 321-323, Railway New colony, Visakhapatnam-530016, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
91-9440608752
amcorthopaedics@hotmail.com |
| Dr Pulkit Maniar |
Parikh Multispecialty Health Care Pvt Ltd |
CT dept Ground floor A4 Bhagwati Park Opp Tube Company Near Gajanan Complex Old Padra Road Vadodara Gujarat 390020
Vadodara
GUJARAT |
09913970010
drpulkitmaniar@gmail.com |
| Dr Parag Tank |
Shardaben Chimanlal Lalbhai Municipal General Hospital |
Department of Orthopedic, Smt. SCL General Hospital & NHL MMC, Ahmedabad - 380018
Ahmadabad
GUJARAT |
09106633217
dr.paragtanknm@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics committee Swami Rama Himalayan University |
Approved |
| Institutional Ethics Committee BIMS, |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, AlIMS |
Approved |
| Institutional Ethics Committee, Medigene |
Approved |
| Jupiter Hospital And Research Centre Institutional Ethics Committee |
Approved |
| Lakeview Ethics Committee |
Approved |
| Parikh Institutional Ethics Committee |
Approved |
| Smt. NHL Municipal Medical College V S Hospital Campus |
Approved |
| Zenith Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Febuxostat ER tablet 40 mg/80 mg |
Febuxostat ER tablet 40 mg (1 tablet) once daily. For patients who do not achieve a serum uric acid less than 6 mg/dl after 2 weeks with 40 mg, febuxostat 80 mg (2 tablets) is recommended once daily. |
| Comparator Agent |
Febuxostat IR tablet 40 mg/80 mg |
Febuxostat IR tablet 40 mg (1 tablet) once daily. For patients who do not achieve a serum uric acid less than 6 mg/dl after 2 weeks with 40 mg, febuxostat 80 mg (2 tablets) is recommended once daily. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects of age between 18 to 65 years (both inclusive.)
2. Subjects with history of chronic hyperuricemia (uric acid level >6.8 mg/dL).
3. Subjects with history of Gout as defined by ACR criteria.
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects with suspected hypersensitivity to the study medication or any of the ingredients of the formulation.
2. Subjects with serum uric acid levels >15 mg/dl.
3. Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
4. Subjects with abnormal eGFR (<30 mL/min/1.73 m2) will be excluded from the study.
5. Subjects with known case of Type 1 Diabetes will be excluded from the study.
6. Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study.
7. Subjects with history of uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) within the past 6 months.
8. Subjects with known case of infection with hepatitis B, hepatitis C or HIV.
9. Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias will be excluded from the study.
10. Subjects with known case of Stroke will be excluded from the study.
11. Subjects with history of any Oncological Conditions since last 5 years will be excluded from the study.
12. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
13. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
14. Subjects currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
15. Suspected inability or unwillingness to comply with the study procedures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of change in percentage of patients with serum urate concentration < 6mg/dl from baseline |
Time frame baseline, Week 2, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study |
Time frame baseline, Week 2, Week 8, Week 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 3 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is randomized, open-label, comparative, active-controlled, multicentric study comparing the safety and efficacy of Febuxostat ER tablet and Febuxostat IR tablet for 12 weeks in chronic management of hypuricemia in 200 patients with gout. Total 200 patients are proposed to be enrolled. The primary outcome measure will be change in percentage of patients with serum urate concentration < 6mg/dl from baseline [Time frame: Week 2, Week 8, Week12] and secondary outcome measure will be evaluation of Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study. The anticipated date of enrollment will be Mar 2024. This study is proposed to be conducted in India only |