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

Last updated on November 13, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Official Title  ICMJE 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)
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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: April 13, 2016)
357
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2012)
300
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion DateSeptember 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 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
Removed Location CountriesCroatia,   Czech Republic,   Norway,   Sweden,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01620255
Other Study ID Numbers  ICMJE A7281009
2012-002030-37 ( EudraCT Number )
TURANDOT ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyShire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountShire
Verification DateMay 2017

ICMJE     Data element required by the

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

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

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Contact

[email protected]

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