A Study of Febuxostat Tablets for treatment of chronic Hyperuricemia

Phase 4

Not yet recruiting

Conditions: Other disorders of purine and pyrimidine metabolism,

Registration Number: CTRI/2018/10/016116

Lead Sponsor: Ajanta Pharma Ltd

Brief Summary: An Open, Prospective, Non-comparative, Multicenter, Post MarketingSurveillance Study to evaluate the Safety and Tolerability of Feburic(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with chronicHyperuricemia.

PrimaryObjective: To evaluate the Safety of Feburic (Febuxostat)Tablets 40 mg / 80 mg / 120 mg in subjects with Chronic Hyperuricemia.

SecondaryObjective: To evaluate the Tolerability of Feburic(Febuxostat) Tablets 40 mg / 80 mg / 120 mg in subjects with ChronicHyperuricemia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 383

Inclusion Criteria

Male or female subjects of age between 18 to 65 years (both inclusive.) 2.
Subjects with history of Gout as defined by ACR criteria.
Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

Subjects with suspected hypersensitivity to the study medication or any of the ingredients of the formulation.
Subjects with serum uric acid levels >15 mg/dl.
Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
Subjects with abnormal eGFR (<30 mL/min/1.73 m2) will be excluded from the study.
Subjects with known case of Type 1 Diabetes will be excluded from the study.
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.
Subjects with history of uncontrolled hypertension (systolic blood pressure â‰¥180 mmHg or diastolic blood pressure â‰¥100 mmHg) within the past 6 months.
Subjects with known case of infection with hepatitis B, hepatitis C or HIV.
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.
Subjects with known case of Stroke will be excluded from the study.
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.
Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
Subjects currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
Suspected inability or unwillingness to comply with the study procedures.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (22): ACSR Govt Medical College and Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Ajanta Research Centre
🇮🇳
Lucknow, UTTAR PRADESH, India
B. J Medical College & Civil Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Brij Medical Center
🇮🇳
Nagar, UTTAR PRADESH, India
Department of Medicine Moti Lal Nehru Medical College
🇮🇳
Allahabad, UTTAR PRADESH, India
Down Town Hospital Ltd
🇮🇳
Jorhat, ASSAM, India
Dr. D. Y. Patil Medical College, Hospital & Research Centre
🇮🇳
Pune, MAHARASHTRA, India
GCS Medical College, Hospital and Research Centre
🇮🇳
Ahmadabad, GUJARAT, India
Grant Government Medical College & Sir J.J Groups of Hospitals
🇮🇳
Mumbai, MAHARASHTRA, India
Jeevan Jyoti Hospital & Research Centre
🇮🇳
Kaushambi, UTTAR PRADESH, India
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ACSR Govt Medical College and Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
Dr Vadddi Suryaprakash
Principal investigator
919490166130
acsrprojects.nellore@gmail.com