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NCT00615199 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
- 20
- Study locations
NCT00615199: Completed Phase 2 study of Crohn's Disease, sponsored by Pfizer.
NCT00615199 is a Phase 2 study of Crohn's Disease that has completed, run by Pfizer. The registered enrollment target is 139 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00615199, a Phase 2 study of Crohn's Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
Primary Outcome
Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activ
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CP-690,550
Study Locations (20)
Florida
- Pfizer Investigational Site - Boca Raton
- Pfizer Investigational Site - Boca Raton
- Pfizer Investigational Site - Boca Raton
- Pfizer Investigational Site - Boca Raton
- Pfizer Investigational Site - Gainesville
- Pfizer Investigational Site - Gainesville
- Pfizer Investigational Site - Jacksonville
- Pfizer Investigational Site - Jacksonville
- Pfizer Investigational Site - St. Petersburg
Colorado
- Pfizer Investigational Site - Boulder
- Pfizer Investigational Site - Lakewood
- Pfizer Investigational Site - Wheat Ridge
Alabama
- Pfizer Investigational Site - Birmingham
- Pfizer Investigational Site - Mobile
Maryland
- Pfizer Investigational Site - Chevy Chase
- Pfizer Investigational Site - Towson
District of Columbia
- Pfizer Investigational Site - Washington D.C.
Illinois
- Pfizer Investigational Site - Chicago
Kansas
- Pfizer Investigational Site - Wichita
Kentucky
- Pfizer Investigational Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00615199 record still lists
NCT00615199 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00615199 names 20 study sites across 8 states, led by Florida, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT00615199 about?
NCT00615199 is a clinical study titled "A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease". This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
What is the current status of trial NCT00615199?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2008-01. Estimated completion is 2009-10.
What conditions does trial NCT00615199 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00615199?
The interventions under investigation include: Placebo (DRUG), CP-690,550 (DRUG).
Who is sponsoring clinical trial NCT00615199?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00615199 being conducted?
This trial has 20 study locations across Alabama, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00615199's enrollment target sits among peer trials
139 61st of 105 higher than 45 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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