A clinical study to assess efficacy and safety of Febuxostat ER Tablet versus Febuxostat IR Tablet

Phase 3

• Conditions: Health Condition 1: I999- Unspecified disorder of circulatory system

• Registration Number: CTRI/2024/01/061844
• Lead Sponsor: AKUMS DRUGS PHARMACEUTICALS LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of change in percentage of patients with serum urate concentration < 6mg/dl from baselineTimepoint: Time frame baseline, Week 2, Week 8, Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the studyTimepoint: Time frame baseline, Week 2, Week 8, Week 12