Trial Outcomes & Findings for Colchicine Or Naproxen Treatment for ACute gouT (NCT NCT01994226)

Results Overview

Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

399 participants

Primary outcome timeframe

Days 0-7

Results posted on

2019-06-18

Participant milestones
Measure	Low-dose Colchicine 500 mcg every eight hours for four days Low-dose colchicine: Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days	Naproxen Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
Overall Study STARTED	199	200
Overall Study COMPLETED	180	179
Overall Study NOT COMPLETED	19	21

Reasons for withdrawal
Measure	Low-dose Colchicine 500 mcg every eight hours for four days Low-dose colchicine: Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days	Naproxen Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
Overall Study Protocol Violation	13	10
Overall Study Early Cessation of treatment	6	11

Colchicine Or Naproxen Treatment for ACute gouT

Baseline characteristics by cohort
Measure	Low-dose Colchicine n=199 Participants 500 mcg every eight hours for four days Low-dose colchicine: Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days	Naproxen n=200 Participants Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days	Total n=399 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 13.4 • n=5 Participants	58.7 years STANDARD_DEVIATION 14.4 • n=7 Participants	59.4 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants	173 Participants n=7 Participants	347 Participants n=5 Participants
Region of Enrollment United Kingdom	199 participants n=5 Participants	200 participants n=7 Participants	399 participants n=5 Participants

Timeframe: Days 0-7

Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome

Outcome measures
Measure	Low-dose Colchicine n=199 Participants 500 mcg every eight hours for four days Low-dose colchicine: Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days	Naproxen n=200 Participants Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
Change in Pain Intensity	3.5 units on a scale Standard Deviation 3.1	3.8 units on a scale Standard Deviation 3.2

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Low-dose Colchicine n=199 participants at risk 500 mcg every eight hours for four days Low-dose colchicine: Route of Administration: Tablet - Oral Use Dose: 500 mcg (one tablet) every eight hours for four days	Naproxen n=200 participants at risk Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days
General disorders Non Cardiac chest pain	0.00% 0/199 • 4 weeks	0.50% 1/200 • Number of events 1 • 4 weeks
Infections and infestations Osteomyelitis	0.50% 1/199 • Number of events 1 • 4 weeks	0.00% 0/200 • 4 weeks
Infections and infestations Complication of TAVI procedure	0.00% 0/199 • 4 weeks	0.50% 1/200 • Number of events 1 • 4 weeks

Adverse event data not reported

Keele University

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