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Completed

NCT Number: NCT05007392

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Dotinurad

Drug

Dotinurad oral tablets.

Other names: FYU-981

Febuxostat

Drug

Febuxostat oral tablets.

Dotinurad Matched Placebo

Other

Dotinurad matched placebo oral tablets.

Febuxostat Matched Placebo

Other

Febuxostat matched placebo oral tablets.

Primary outcomes

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

    Time frame: At Week 24

    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.

Secondary outcomes

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

    Time frame: At Week 12

    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.

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

    Time frame: 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24

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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2021
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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