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A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00787202
First received: November 6, 2008
Last updated: March 6, 2013
Last verified: March 2013
Results First Received: December 4, 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: Ulcerative Colitis
Interventions: Drug: CP- 690 550
Other: 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
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
Placebo Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
CP-690,550 0.5 mg CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
CP-690,550 3 mg CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
CP-690,550 10 mg CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
CP-690,550 15 mg CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.

Participant Flow:   Overall Study
    Placebo   CP-690,550 0.5 mg   CP-690,550 3 mg   CP-690,550 10 mg   CP-690,550 15 mg
STARTED   49   31   33   33   49 
Treated   48   31   33   33   49 
COMPLETED   35   20   26   31   45 
NOT COMPLETED   14   11   7   2   4 
Adverse Event                3                2                0                0                2 
Lack of Efficacy                5                6                5                2                1 
Lost to Follow-up                1                0                0                0                0 
Withdrawal by Subject                2                2                2                0                0 
Protocol Violation                2                1                0                0                1 
Randomized, not treated                1                0                0                0                0 



  Baseline Characteristics
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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
Placebo Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
CP-690,550 0.5 mg CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
CP-690,550 3 mg CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
CP-690,550 10 mg CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
CP-690,550 15 mg CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   CP-690,550 0.5 mg   CP-690,550 3 mg   CP-690,550 10 mg   CP-690,550 15 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   31   33   33   49   195 
Age, Customized 
[Units: Participants]
           
18 to 44 years   28   16   18   17   31   110 
45 to 64 years   16   14   13   15   16   74 
Greater than or equal to (>=) 65 years   5   1   2   1   2   11 
Gender 
[Units: Participants]
           
Female   26   14   14   12   23   89 
Male   23   17   19   21   26   106 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Clinical Response   [ Time Frame: Week 8 ]

2.  Secondary:   Percentage of Participants With Clinical Remission   [ Time Frame: Week 8 ]

3.  Secondary:   Percentage of Participants With Endoscopic Response   [ Time Frame: Week 8 ]

4.  Secondary:   Percentage of Participants With Endoscopic Remission   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12   [ Time Frame: Baseline, Week 2, 4, 8, 12 ]

6.  Secondary:   Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8   [ Time Frame: Baseline, Week 8 ]

7.  Secondary:   Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8   [ Time Frame: Baseline, Week 4, 8 ]

8.  Secondary:   Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12   [ Time Frame: Baseline, Week 2, 4, 8, 12 ]

9.  Secondary:   Plasma Concentration of CP-690,550   [ Time Frame: 0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Pharmacokinetic (PK) parameters and their correlation with clinical response and inflammatory biomarkers were not reported as data from future studies were to be pooled for analysis.


  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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787202     History of Changes
Other Study ID Numbers: A3921063
Study First Received: November 6, 2008
Results First Received: December 4, 2012
Last Updated: March 6, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency