Trial intelligence / Profile preview

CONTACT: Low-dose Colchicine vs Naproxen in Acute Gout

NCT01994226Phase 4

Key facts

Status
Completed
Start
Jan 2014
Primary completion
Mar 2016
Countries
1
Sponsor
Keele University
Modality
Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs
Conditions
gout
01

Overview

Phase 4, randomised, open-label trial of colchicine in gout (2 arms), sponsored by Keele University. Primary endpoint: Change in worst pain intensity in the previous 24 hours. Started Jan 2014; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Low-dose colchicine

    500 mcg every eight hours for four days

  • Naproxen

    750 mg initial dose followed by 250 mg every eight hours for up to seven days

03

Who it enrols

Adults 18+ with acute gout attack. Excludes CKD stage 4/5, unstable medical conditions, recent GI bleed/ulcer, anticoagulant use, and pregnancy.

04

Endpoints

Primary

  • Change in worst pain intensity in the previous 24 hours

Secondary

  • Side effects

  • Time to treatment response

  • Patient global assessment of response to treatment

  • Adherence to treatment

  • Use of other medications for pain relief

  • Cost effectiveness

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