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

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NCT00787202

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Study Location
Pfizer Investigational Site
Antwerpen, , 2020, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients must be at least 18 years of age at screening

- Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.

- Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6

- Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Diagnosis of Crohn's disease or diagnosis of indeterminate colitis


- Treatment naive subjects who have not had previous exposure to treatment for
ulcerative colitis


- Patients that are currently receiving immunosuppressants, anti-TNFα therapy or
interferon

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
Official Title  ICMJE A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Brief Summary The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: CP- 690 550
    Administration via oral route twice daily for the duration of treatment
  • Other: placebo
    Administration via oral route twice daily for the duration of treatment
Study Arms  ICMJE
  • Experimental: 15 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 10 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 3 mg BID
    Intervention: Drug: CP- 690 550
  • Experimental: 0.5 mg BID
    Intervention: Drug: CP- 690 550
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2013)		195
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2008)		192
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be at least 18 years of age at screening
  • Males and female patients with clinical diagnosis of ulcerative colitis ?3 months prior to entry into the study.
  • Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ?6
  • Patients with endoscopic sub-score of ?2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

  • Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
  • Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
  • Patients that are currently receiving immunosuppressants, anti-TNF? therapy or interferon
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Chile,   Czech Republic,   Denmark,   France,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT00787202
Other Study ID Numbers  ICMJE A3921063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP