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Trial record 23 of 188 for:    "Gout"

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Low-dose Colchicine   Naproxen
STARTED   199   200 
COMPLETED   180   179 
NOT COMPLETED   19   21 
Protocol Violation                13                10 
Early Cessation of treatment                6                11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Low-dose Colchicine   Naproxen   Total 
Overall Participants Analyzed 
[Units: Participants]
 199   200   399 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (13.4)   58.7  (14.4)   59.4  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  12.6%      27  13.5%      52  13.0% 
Male      174  87.4%      173  86.5%      347  87.0% 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   199   200   399 


  Outcome Measures

1.  Primary:   Change in Pain Intensity   [ Time Frame: Days 0-7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: research.governance@keele.ac.uk



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