Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout

November 9, 2023 updated by: National Taiwan University Hospital

Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Ages Eligible for Study: more than 20 years

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose titration group
Stepwise dose titration of febuxostat and low-dose colchicine
Drug: Stepwise dose titration of febuxostat and low-dose colchicine
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
Active Comparator: Standard treatment group
Fixed dose febuxostat and low-dose colchicine
Drug: Fixed dose febuxostat and low-dose colchicine
Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of gout flare during the first 12 weeks.
Time Frame: 12 weeks
The percentage of the patients suffered from gout flare during the first 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of gout flares per patient during the first 12 weeks
Time Frame: 12 weeks
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
Time Frame: 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
Time Frame: 12, 24 weeks
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
12, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Taiwan University Hospital, Yun-Lin Branch

Investigators

  • Principal Investigator: Yi-Min Huang, National Taiwan University Hospital, Yun-Lin branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

August 23, 2023

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202009131MIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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