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Colchicine Or Naproxen Treatment for ACute gouT (CONTACT)

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ClinicalTrials.gov Identifier: NCT01994226
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Keele University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Low-dose colchicine
Drug: Naproxen 750 mg/250 mg
Enrollment 399

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low-dose Colchicine Naproxen
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 199 200
Completed 180 179
Not Completed 19 21
Reason Not Completed
Protocol Violation             13             10
Early Cessation of treatment             6             11
Arm/Group Title Low-dose Colchicine Naproxen Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 199 200 399
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 200 participants 399 participants
60  (13.4) 58.7  (14.4) 59.4  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 200 participants 399 participants
Female
25
  12.6%
27
  13.5%
52
  13.0%
Male
174
  87.4%
173
  86.5%
347
  87.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 199 participants 200 participants 399 participants
199 200 399
1.Primary Outcome
Title Change in Pain Intensity
Hide Description Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome
Time Frame Days 0-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-dose Colchicine Naproxen
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 199 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.4  (2.7) 1.4  (2)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-dose Colchicine Naproxen
Hide Arm/Group Description

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

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

All-Cause Mortality
Low-dose Colchicine Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)      0/200 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Low-dose Colchicine Naproxen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/199 (0.50%)      2/200 (1.00%)    
General disorders     
Non Cardiac chest pain  1  0/199 (0.00%)  0 1/200 (0.50%)  1
Infections and infestations     
Osteomyelitis  1  1/199 (0.50%)  1 0/200 (0.00%)  0
Complication of TAVI procedure  1  0/199 (0.00%)  0 1/200 (0.50%)  1
1
Term from vocabulary, CTCAE
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low-dose Colchicine Naproxen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/199 (0.00%)      0/200 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sponsor
Organization: Keele University
Phone: 01782 ext 734882
Responsible Party: Keele University
ClinicalTrials.gov Identifier: NCT01994226     History of Changes
Other Study ID Numbers: 149/11
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: April 12, 2017
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018