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A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00615199
First received: January 14, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: CP-690,550
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
CP-690550 1 mg CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
CP-690550 5 mg CP-690550 5 mg tablet orally twice daily for 4 weeks.
CP-690550 15 mg CP-690550 15 mg tablet orally twice daily for 4 weeks.

Participant Flow:   Overall Study
    Placebo     CP-690550 1 mg     CP-690550 5 mg     CP-690550 15 mg  
STARTED     34     36     34     35  
COMPLETED     26     34     33     33  
NOT COMPLETED     8     2     1     2  
Adverse Event                 3                 1                 1                 0  
Lack of Efficacy                 2                 0                 0                 1  
Lost to Follow-up                 1                 0                 0                 0  
Unspecified                 0                 0                 0                 1  
Withdrawal by Subject                 2                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
CP-690550 1 mg CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
CP-690550 5 mg CP-690550 5 mg tablet orally twice daily for 4 weeks.
CP-690550 15 mg CP-690550 15 mg tablet orally twice daily for 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     CP-690550 1 mg     CP-690550 5 mg     CP-690550 15 mg     Total  
Number of Participants  
[units: participants]
 		  34     36     34     35     139  
Age  
[units: years]
Mean ± Standard Deviation 		  35.7  ± 12.7     36.6  ± 12.2     38.7  ± 10.2     38.1  ± 11.7     37.3  ± 11.7  
Gender  
[units: participants]
 		         
Female     22     11     20     17     70  
Male     12     25     14     18     69  



  Outcome Measures
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1.  Primary:   Number of Participants With Clinical Response 70 at Week 4   [ Time Frame: Week 4 ]
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2.  Secondary:   Number of Participants With Clinical Response 70 at Week 1 and 2   [ Time Frame: Week 1, 2 ]
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3.  Secondary:   Number of Participants Achieving Clinical Remission at Week 4   [ Time Frame: Week 4 ]
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4.  Secondary:   Number of Participants With Clinical Response 100 at Week 4   [ Time Frame: Week 4 ]
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5.  Secondary:   Time to First Clinical Remission   [ Time Frame: Week 1 through Week 4 ]
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6.  Secondary:   Time to First Response 70   [ Time Frame: Week 1 through Week 4 ]
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7.  Secondary:   Time to First Response 100   [ Time Frame: Week 1 through Week 4 ]
  Show Outcome Measure 7


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
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Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00615199     History of Changes
Other Study ID Numbers: A3921043
Study First Received: January 14, 2008
Results First Received: November 28, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration