A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
NCT00787202
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 |
| |||
| Study Arms ICMJE |
| |||
| 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 | 195 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||