CTRI/2018/10/016116 [Registered on: 23/10/2018] Trial Registered Prospectively
Last Modified On:
07/05/2019
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Other
Public Title of Study
A Study of Febuxostat Tablets for treatment of chronic Hyperuricemia
Scientific Title of Study
An Open, Prospective, Non-comparative, Multicenter, Post Marketing Surveillance Study to evaluate the Safety and Tolerability of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with chronic Hyperuricemia.
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Venkat Arjunrao Gite
Designation
Principal Investigator
Affiliation
Grant Government Medical College & Sir J. J. Group of Hospitals
Address
Main OPD Building, OPD No. 28, First Floor, Grant Government Medical College & Sir J. J. Group of Hospitals, Byculla, Mumbai- 400008, Maharashtra, India
ACSR Govt Medical College and Hospital, 1 st floor DPT Clinical Research, GNT Road, Dargamitta, Nellore-524004, Andhrapradesh, India Nellore ANDHRA PRADESH
919490166130
acsrprojects.nellore@gmail.com
Dr Deepak Dewan
Ajanta Research Centre
Ajanta Research Centre, Ajanta Hospital & IVF Centre 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226005 Lucknow UTTAR PRADESH
B. J Medical College & Civil Hospital, Department of Urology, B. J Medical College & Civil Hospital, Asarwa, Ahemdabad-380016, Gujrat, India. Ahmadabad GUJARAT
9979889478
kalpeshkkapadia@gmail.com
Dr Amod Kumar Dwivedi
Brij Medical Center
Brij Medical Center Pvt Ltd, 94-E, Near Panki Police station, Panki, Kanpur, U.P. 208020 Kanpur Nagar UTTAR PRADESH
08795258444
lobe1617@gmail.com
Dr Arvind Gupta
Department of Medicine Moti Lal Nehru Medical College
MLN Medical College, Allahabad Uttar Pradesh-211001, India. Allahabad UTTAR PRADESH
919415340681
dr.arvind.nephro@gmai.com
Dr Nandita Choudhury
Down Town Hospital Ltd
1st Building, 5 th Floor, Room No.: 517, Down Town Hospital, G.S. Road, Dispur, Guwahati-781006, Assam. Jorhat ASSAM
Dr. D. Y. Patil Medical College, Hospital & Research Centre
Department of Urology, Dr. D. Y. Patil Medical College, Hospital & Research Centre, Pimpri, Pune-411018, Maharashtra, India. Pune MAHARASHTRA
9822208145
vikramsatav@yahoo.com
Dr Dala Saurin Pinakin
GCS Medical College, Hospital and Research Centre
GCS Medical College, Hospital and Research Centre, Opp. DRM Office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad – 380025. Gujarat, India Ahmadabad GUJARAT
919824301805 077922201915 dalalsaurin@yahoo.com
Dr Venkat Arjunrao Gite
Grant Government Medical College & Sir J.J Groups of Hospitals
Department of Urology, Grant Government Medical College & Sir J.J Groups of Hospitals, Mumbai-400008. Mumbai MAHARASHTRA
919011654646
balajigite@yahoo.com
Dr Vipul Tandon
Jeevan Jyoti Hospital & Research Centre
Jeevan Jyoti Hospital & Research Centre, 162, Bai ka Bagh, Lowther Road, Allahabad-211003, UP. India. Kaushambi UTTAR PRADESH
919335124958
urologyresearchjjh@gmail.com
Dr SN Sankhwar
King Georges Medical University
King Georges Medical University, Shahmina Road, Chowk, Lucknow-226003, uttar Pradesh, India. Lucknow UTTAR PRADESH
915222257450 915222257539 sankhwarsn_sn@yahoo.com
Dr Malikarjun S karishetti
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belgavi-590010. Belgaum KARNATAKA
Lourdes Hospital, Pachalam, Kochi-682012 Kozhikode KERALA
09847056690 04842393720 dr.moorthy65@gmail.com
Dr Ashok Kumar Gupta
Maharaja Agrasen Hospital
Maharaja Agrasen Hospital, West Punjab Bagh, New Delhi-110026. New Delhi DELHI
9810046353 01125225403 akg.urogyn@gmail.com
Dr Shivanshu Singh
Om Research Center, Om Surgical Center & Maternity Home
Om Research Center, Om Surgical Center & Maternity Home, SA-17/3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Road, Varanasi-221007. Varanasi UTTAR PRADESH
9415226817 05422588849 omresearchcenter@gmail.com
Dr Samir Govil
Post Graduate Department of Medicine G.S.V.M. Medical College, Kanpur
Post Graduate Department of Medicine G.S.V.M. Medical College, Swaroop Nagar Kanpur-208002 Kanpur Nagar UTTAR PRADESH
918726555577 7922201915 nephroknp@gmail.com
Dr Nipun AC
Rajalakshmi Hospital
Rajalakshmi Hospital Vidyaranyapura post, Lakshmipura Main Road Bangalore-560097 Bangalore KARNATAKA
08023254855 08023254855 adrnipun@gmail.com
Dr A Appalaraju
Rajiv Gandhi Institute of Medical Science & RIMS Govt. General Hospital
Department of Surgery, Rajiv Gandhi Institute of Medical Science & RIMS Govt. General Hospital,Srikakulam-532001, Andhra Pradesh, India. Srikakulam ANDHRA PRADESH
8942279033
draappalaraju@gmail.com
Dr Vipul Vasantrao Chakurkar
Sasson General Hospital
Sassoon General Hospital,Jay Prakash Narayan Road, Near Pune Railway Station, Pune 411001, Maharashtra, India. Pune MAHARASHTRA
The recommended starting dose of Febuxostat Tablets is 40 mg once daily. For subjects who do not achieve a serum uric acid (sUA) level less than 6 mg/dL after 2 weeks with Febuxostat 40 mg, then 80 mg dose is recommended and also for those subjects who do not achieve a serum uric acid (sUA) level less than 6 mg/dL after 2 weeks with Febuxostat 80 mg, then 120 mg dose is recommended
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 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
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the Safety of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.
At the end of 28 weeks
Secondary Outcome
Outcome
TimePoints
To evaluate the Tolerability of Feburic (Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia
At the end of 28 weeks
Target Sample Size
Total Sample Size="383" Sample Size from India="383" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
An Open, Prospective, Non-comparative, Multicenter, Post Marketing
Surveillance Study to evaluate the Safety and Tolerability of Feburic
(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with chronic
Hyperuricemia.
Primary
Objective: To evaluate the Safety of Feburic (Febuxostat)
Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.
Secondary
Objective: To evaluate the Tolerability of Feburic
(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic
Hyperuricemia.