GoutNCT04697602
Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
A study testing Stepwise dose titration of febuxostat and low-dose colchicine and Fixed dose febuxostat and low-dose colchicine in people with Gout, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Gout
- What is being tested?
- Stepwise dose titration of febuxostat and low-dose colchicine and Fixed dose febuxostat and low-dose colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jan 2021to 23 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
- Acute gout attack during the last 12 months
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gout
- Being tested
- Stepwise dose titration of febuxostat and low-dose colchicine, Fixed dose febuxostat and low-dose colchicine
- Keywords
- gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Dose titration group | Experimental | Stepwise dose titration of febuxostat and low-dose colchicine Receives: Drug: Stepwise dose titration of febuxostat and low-dose colchicine |
| Standard treatment group | Active comparator | Fixed dose febuxostat and low-dose colchicine Receives: Drug: Fixed dose febuxostat and low-dose colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
The number of gout flares per patient during the first 12 weeks
The number of gout flares per patient during the first 12 weeks
Measured: 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
Measured: 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
Measured: 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start20 Jan 2021
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
- Investigators
- Yi-Min Huang, Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697602
- Sponsor's protocol ID
- 202009131MIND
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2021
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04697602
- Acronym / sponsor ID
- 202009131MIND
- Conditions
- Gout
- Keywords
- gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose titration group | Experimental | Drug: Stepwise dose titration of febuxostat and low-dose colchicineStepwise dose titration of febuxostat and low-dose colchicine |
| Standard treatment group | Active comparator | Drug: Fixed dose febuxostat and low-dose colchicineFixed dose febuxostat and low-dose colchicine |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
- Acute gout attack during the last 12 months
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepwise dose titration of febuxostat and low-dose colchicineFebuxostat 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 | Drug | Dose titration group |
| Fixed dose febuxostat and low-dose colchicineFebuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12 | Drug | Standard treatment group |
Primary outcome
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.
3 secondary outcomes
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 second 12 weeks
Time frame: 12 weeks
The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
Time frame: 12, 24 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Min Huang principal investigator
National Taiwan University Hospital, Yun-Lin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise dose titration of febuxostat and low-dose colchicine and Fixed dose febuxostat and low-dose colchicine in people with Gout, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
The incidence rate of gout flare during the first 12 weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2023.