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NCT05006001 Clinical Trial

Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Gout Clinical Trial

Official title:
Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05006001
Other study ID # EnChuKongH
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 31, 2024

Study information
Verified date August 2021
Source En Chu Kong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Description:

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent. Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of a gout diagnosis - Initially receiving at least one anti-gout drug Exclusion Criteria: - <1 year of continuous health insurance enrollment - Colchicine and NSAID use before the cohort entry date - Patients with hemodialysis or peritoneal dialysis before the cohort entry date - Patients with acute kidney injury before the cohort entry date

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Colchicine and NSAID
Colchicine and nonsteroidal anti-inflammatory drug combination therapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
En Chu Kong Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Acute kidney injury Number of participants with a diagnosis of acute kidney injury Through study completion, an average of 1 year
Secondary All cause mortality Number of participants with a death record Through study completion, an average of 1 year
Secondary Hemodialysis or peritoneal dialysis Number of participants with a dialysis record Through study completion, an average of 1 year
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