Skip to content

"Pill in the pocket" strategy for the prevention of gout flares during the initial phase of urate lowering therapy: A prospective, multi-center, randomized, active comparator open-label non-inferiority study

"Pill in the pocket" strategy for the prevention of gout flares during the initial phase of urate lowering therapy: A prospective, multi-center, randomized, active comparator open-label non-inferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107149
Enrollment
Unknown
Registered
2025-08-05
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

intervention group:Fixed-dose febuxostat (40 mg once daily) plus PIP strategy: colchicine was given as a loading dose of 1 mg within 12 hours of the patient experiencing a gouty aura such as tingling
control group:Fixed-dose febuxostat (40 mg once daily) plus low-dose colchicine (0.5 mg once daily)

Sponsors

The Second Affiliated Hospital Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male patients older than 18 years of age; 2. Experienced at least one gouty arthritis attack within one year prior to study enrollment; 3. Serum uric acid level greater than 7.0 mg/dL; 4. Not on uric acid-lowering medication for at least one month prior to study entry; 5. Participants should have experienced at least one gouty aura.

Exclusion criteria

Exclusion criteria: 1. Patients who have had gouty arthritis in the two weeks prior to the study date; 2. Are younger than 18 years of age; 3. History of allergy to febuxostat, colchicine, or NSAIDs; 4. Serious comorbidities, including serum creatinine levels of 2.0 mg/dL or greater; 5. Patient is considered by the investigator to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of gouty attacks;

Secondary

MeasureTime frame
Cumulative dose of colchicine;Percentage of patients achieving blood uric acid <=6.0 mg/dL;Adverse events and adverse reactions;

Countries

China

Contacts

Public ContactLei Liu

The Second Affiliated Hospital Zhejiang University School of Medicine

liu_lei@zju.edu.cn+86 159 6883 1213

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026