NCT04697602

Brief Summary

The purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

January 5, 2021

Last Update Submit

November 9, 2023

Conditions

Gout

Keywords

gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of gout flare during the first 12 weeks.

    The percentage of the patients suffered from gout flare during the first 12 weeks.

    12 weeks

Secondary Outcomes (3)

  • The number of gout flares per patient during the first 12 weeks

    12 weeks

  • The number of gout flares per patient during the second 12 weeks

    12 weeks

  • The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks

    12, 24 weeks

Study Arms (2)

Dose titration group

EXPERIMENTAL

Stepwise dose titration of febuxostat and low-dose colchicine

Drug: Stepwise dose titration of febuxostat and low-dose colchicine

Standard treatment group

ACTIVE COMPARATOR

Fixed dose febuxostat and low-dose colchicine

Drug: Fixed dose febuxostat and low-dose colchicine

Interventions

Stepwise dose titration of febuxostat and low-dose colchicineDRUG

Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12

Dose titration group
Fixed dose febuxostat and low-dose colchicineDRUG

Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12

Standard treatment group

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
  • Acute gout attack during the last 12 months

You may not qualify if:

  • Acute gout attack in the last 2 weeks
  • Urate-lowering therapy in the last 4 weeks
  • Secondary hyperuricemia
  • Creatinine ≥2.0 mg/dL
  • AST or ALT ≥2x upper limits of normal
  • Heart failure (NYHA III-IV)
  • Hypersensitivity to colchicine, NSAID or febuxostat
  • Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
  • Inability to comply with the protocol requirements
  • The judgement of the investigator that the patient was not an appropriate candidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Gout

Interventions

ColchicineFebuxostat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yi-Min Huang

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 6, 2021

Study Start

January 20, 2021

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

TW(1)