UnknownPhase 1

A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults

90 participantsStarted 2022-04-30

Plain-language summary

The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 - 65 years old, male or female.
. BMI: 18.0 - 30 kg/m2.
. Meet the 2015 ACR (American College of Rheumatology) gout classification criteria.
. Fasting serum uric acid ≥480 μmol/L on 2 different days during the screening period.
. Willing to use contraceptive measures during the study.
. Able and willing to provide a written informed consent.

Exclusion criteria

. History of acute gout attack within 4 weeks before randomization.
. Urinary calculi diagnosed by B-ultrasound within 4 weeks before randomization.
. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
. Major cardiovascular disease within 6 months before randomization.
. History of chronic infection or recurrent infection within 1 year before randomization.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.

Timeframe: on Day 15.

Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)

Timeframe: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29

Trial details

NCT IDNCT05347498

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-31

Contact for this trial

Huize Han

+0518-82342973 huize.han@hengrui.com

View on ClinicalTrials.gov More Primary Gout With Hyperuricemia in Adults trials