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A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Mayo Clinic Arizona
Scottsdale, Arizona, 85259 United States
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with diagnosis of Ulcerative Colitis for 3 or more months.

- Ulcerative colitis must be active beyond the rectum.

- Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

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

- Pregnant or breast feeding.

- Diagnosis of indeterminate colitis or Crohn's Disease

- Subjects with history of colonic or small bowel obstruction or resection.

NCT01620255
Pfizer
Completed
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

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A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: Placebo
    Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC Injection
    Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC Injection
    Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC Injection
    Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC Injection
    Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Drug Dose Level 1
    Intervention: Drug: PF-00547659 SC Injection
  • Experimental: Drug Dose Level 2
    Intervention: Drug: PF-00547659 SC Injection
  • Experimental: Drug Dose Level 3
    Intervention: Drug: PF-00547659 SC Injection
  • Experimental: Drug Dose Level 4
    Intervention: Drug: PF-00547659 SC Injection
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
February 2016
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
  • Ulcerative colitis must be active beyond the rectum.
  • Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Diagnosis of indeterminate colitis or Crohn's Disease
  • Subjects with history of colonic or small bowel obstruction or resection.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   United States
Croatia,   Czech Republic,   Norway,   Sweden,   United Kingdom
 
NCT01620255
A7281009
2012-002030-37 ( EudraCT Number )
TURANDOT ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Shire
May 2017

ICMJE     Data element required by the

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

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