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MPC-004 for the Treatment of an Acute Gout Flare (AGREE)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00506883
First received: July 23, 2007
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
Results First Received: August 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gout
Interventions: Drug: High Dose Colchicine (4.8 mg total dose)
Drug: Low Dose Colchicine (1.8mg total dose)
Other: Placebo Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In 2007 between 4 April and 3 December 813 patients were screened at 74 US treatment centers. 72 centers randomized a total 575 patients. 185 patients at 54 centers had a qualifying gout flare and 184 are included in the ITT population. The remaining, 390 patients had no flare or had a flare that failed to qualify for study medication use

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
813 patients with confirmed diagnosis of gout based on American College of Rheumatology criteria were screened. 575 patients qualified and were randomized within 28 days of screening. 238 patients failed screening. The vast majority, 235 (98.7%) failed to meet inclusion/exclusion criteria.

Reporting Groups
  Description
High Dose Colchicine(MPC-004) Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
Low Dose Colchicine(MPC-004) Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
Placebo Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.

Participant Flow:   Overall Study
    High Dose Colchicine(MPC-004)     Low Dose Colchicine(MPC-004)     Placebo  
STARTED     52     74     59  
COMPLETED     45     71     55  
NOT COMPLETED     7     3     4  
Lost to Follow-up                 1                 1                 1  
Withdrawal by Subject                 1                 0                 1  
Lack of Efficacy                 0                 1                 1  
Other                 5                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
High Dose Colchicine(MPC-004) Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
Low Dose Colchicine(MPC-004) Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
Placebo Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
Total Total of all reporting groups

Baseline Measures
    High Dose Colchicine(MPC-004)     Low Dose Colchicine(MPC-004)     Placebo     Total  
Number of Participants  
[units: participants]
 		  52     74     59     185  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     46     61     53     160  
>=65 years     6     13     6     25  
Age  
[units: years]
Mean ± Standard Deviation 		  51.9  ± 10.02     51.4  ± 11.79     51.2  ± 11.36     51.5  ± 11.12  
Gender  
[units: participants]
 		       
Female     3     2     4     9  
Male     49     72     55     176  



  Outcome Measures

1.  Primary:   Responders   [ Time Frame: 24 hours after baseline ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: AR Scientific, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com


No publications provided by Takeda Global Research & Development Center, Inc.

Publications automatically indexed to this study:


Responsible Party: Matthew Davis, MD, AR Scientific
ClinicalTrials.gov Identifier: NCT00506883     History of Changes
Other Study ID Numbers: MPC 004-06-3001
Study First Received: July 23, 2007
Results First Received: August 12, 2009
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration