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

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01620255
First received: June 13, 2012
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Drug: PF-00547659 SC Injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, Parallel, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-00547659 In Subjects With Moderate To Severe Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects in Clinical Remission as defined by a Total Mayo Score of 2 points or lower with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with a Clinical Response with a decrease in Total Mayo Score by at least 3 points and at least 30% decrease in subscore for rectal bleeding of at least 1 point or absolute subscore of 0 or 1. [ Time Frame: Week 0, 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with mucosal healing (defined as absolute Mayo subscore of endoscopy of 0 or 1). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proporation of subjects with change in partial Mayo Score of less than or equal to 2 with no individual subscore greater than 1. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in Mayo Score and in individual Mayo subscores. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in fecal calprotectin. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in high sensitivity C-reactive protein. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change over time in the mean Inflammatory Bowel Disease Questionnaire domain and total scores. [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with an Inflammatory Bowel Disease Questionnaire total score of greater than or equal to 170. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • PF-00547659 concentration-time profile [ Time Frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: PF-00547659 SC Injection
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 1 Drug: PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 2 Drug: PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 3 Drug: PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 4 Drug: PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620255

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01620255     History of Changes
Other Study ID Numbers: A7281009
Study First Received: June 13, 2012
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013