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GoutPhase 3NCT05007392

A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

A Phase 3 study testing Dotinurad and Febuxostat in people with Gout, run by Eisai Co., Ltd. at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gout
What is being tested?
Dotinurad and Febuxostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
30 sitesChina
Study dates
21 Dec 2021to 14 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization)
  • Male or female participant with age greater than or equal to (>=) 18 years at the time of informed consent
  • Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study

Who cannot join

  • Has gouty arthritis that has not resolved within 14 days prior to randomization
  • Has secondary hyperuricemia
  • Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)
  • Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
  • Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in the screening phase
  • Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter per minute/1.73 square meters in the screening phase
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  • Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic blood pressure of >=110 mmHg in the screening phase
  • Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4 percent (%) in the screening phase
  • Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • First Affiliated Hospital of Inner Mongolia technological University

    Baotou, Inner Mongolia, 14010

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Beijing Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China

    Beijing, Beijing Municipality, 101100

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410013

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 210300

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning, 116021

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Foshan First People's Hospital

    Foshan, Guangdong, 528000

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10050

  • Jieyang People's Hospital

    Jieyang, Guangdong

  • The First People's Hospital of Yunnan Province

    Kunming, Yun'nan, 650032

  • Nanjing Medical University Affiliated 2nd Hospital

    Nanjing, Jiangsu, 210011

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Tong Ren Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200050

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai Municipality, 200052

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    Shenzhen, Guangdong, 200090

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

  • Yanbian University Hospital

    Yanji, Jilin, 133000

Other trials in China

About this study

Official title: A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout

The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout.

Conditions
Gout
Being tested
Dotinurad, Febuxostat, Dotinurad Matched Placebo, Febuxostat Matched Placebo
Keywords
Dotinurad, Febuxostat
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DotinuradDrug

    Also called FYU-981

    Dotinurad oral tablets.

  • FebuxostatDrug

    Febuxostat oral tablets.

  • Dotinurad Matched PlaceboOther

    Dotinurad matched placebo oral tablets.

  • Febuxostat Matched PlaceboOther

    Febuxostat matched placebo oral tablets.

Study groups in NCT05007392
Study groupRoleWhat they receive
Drug: Dotinurad + Febuxostat Matched PlaceboExperimentalParticipants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).
Receives: Drug: Dotinurad; Other: Febuxostat Matched Placebo
Drug: Febuxostat + Dotinurad Matched PlaceboActive comparatorParticipants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).
Receives: Drug: Febuxostat; Other: Dotinurad Matched Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)

    Percentage of participants with SUA level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.

    Measured: At Week 24

Secondary outcomes (5)

  1. Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)

    Percentage of participants with SUA level <=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.

    Measured: At Week 12

  2. Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24

    Percentage of participants with SUA level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.

    Measured: At Weeks 4, 8, 12, 16, 20 and 24

  3. Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24

    Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.

    Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24

  4. Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24

    Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.

    Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24

  5. Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24

    Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.

    Measured: Baseline, Weeks 4, 8, 12, 16, 20 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start21 Dec 2021
  3. Primary completion14 Jun 2023
  4. Study completion14 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007392
Sponsor's protocol ID
FYU-981-J086-301
Status last verified
Jul 2025
First submitted
11 Aug 2021
Last updated
30 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dotinurad and Febuxostat in people with Gout, run by Eisai Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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