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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Antwerpen, , 2020 Belgium
Contact
1-800-718-1021
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-TNF? therapy or
interferon

NCT00787202
Pfizer
Completed
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

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A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • 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
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Chile,   Czech Republic,   Denmark,   France,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom
Turkey
 
NCT00787202
A3921063
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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