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

Primary Purpose

Gout

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Stepwise dose titration of febuxostat and low-dose colchicine
Fixed dose febuxostat and low-dose colchicine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dose titration group

Standard treatment group

Arm Description

Stepwise dose titration of febuxostat and low-dose colchicine

Fixed dose febuxostat and low-dose colchicine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The number of gout flares per patient during the first 12 weeks
The number of gout flares per patient during the first 12 weeks
The number of gout flares per patient during the second 12 weeks
The number of gout flares per patient during the second 12 weeks
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks

Full Information

First Posted
January 5, 2021
Last Updated
September 15, 2022
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch
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1. Study Identification

Unique Protocol Identification Number
NCT04697602
Brief Title
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose titration group
Arm Type
Experimental
Arm Description
Stepwise dose titration of febuxostat and low-dose colchicine
Arm Title
Standard treatment group
Arm Type
Active Comparator
Arm Description
Fixed dose febuxostat and low-dose colchicine
Intervention Type
Drug
Intervention Name(s)
Stepwise dose titration of febuxostat and low-dose colchicine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fixed dose febuxostat and low-dose colchicine
Intervention Description
Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
Primary Outcome Measure Information:
Title
The incidence rate of gout flare during the first 12 weeks.
Description
The percentage of the patients suffered from gout flare during the first 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The number of gout flares per patient during the first 12 weeks
Description
The number of gout flares per patient during the first 12 weeks
Time Frame
12 weeks
Title
The number of gout flares per patient during the second 12 weeks
Description
The number of gout flares per patient during the second 12 weeks
Time Frame
12 weeks
Title
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
Description
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
Time Frame
12, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ages Eligible for Study: more than 20 years Inclusion Criteria: Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria Acute gout attack during the last 12 months Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Min Huang
Phone
0972655455
Email
zeamayschang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Min Huang
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Min Huang
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YIMIN HUANG
Email
zeamayschang@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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