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Clinical Trials/EUCTR2013-000366-11-BE
EUCTR2013-000366-11-BEActive, not recruitingPhase 1

A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)

Tillotts Pharma AG0 sites800 target enrollmentStarted: July 11, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
800
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •(1) Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomisation, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
  • •(2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge: the diagnosis of UC is based on the site investigator's assessment and should be available at randomization.
  • •(3) Active UC defined by:
  • •a. Mayo score of > 5
  • •b. Sigmoidoscopy component score = 2 confirmed by central review and
  • •c. Rectal bleeding component score = 1
  • •(4) Ability of the subject to participate fully in all aspects of this clinical trial.
  • •(5) Written informed consent must be obtained and documented.
  • •(1) Attendance at the Week 8 visit and completion of disease activity assessments prior to enrolment in OLE at Week 12 (responders or remitters) or Week 8 (non-responders).
  • •(2) At least 75% compliance with study medication in the induction phase.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 752
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

  • •(1) Severe UC defined by the following criteria:
  • •? 6 bloody stools daily with one or more of the following:
  • •a. oral temperature > 37.8?C or > 100.0?F
  • •b. pulse > 90 beats/min
  • •c. haemoglobin < 10 g/dL
  • •(2) Proctitis: distal disease involving the rectum only i.e. disease extending less than 15 cm from the anal verge.
  • •(3) Treatment with oral mesalamine at a dose of > 2.5 g/day within 4 weeks prior to randomisation. Pre-study mesalamine therapy at a dose of 2.5g/day or less must be stopped at Visit 2.
  • •(4) Treatment with rectal mesalamine within 2 weeks prior to randomisation
  • •(5) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation.
  • •(6) Treatment with immunosuppressants within 6 weeks prior to randomisation.
  • •(7) Treatment with infliximab or other biologics within 3 months prior to randomisation.
  • •(8) Treatment with antibiotics within 7 days prior to randomisation.
  • •(9) Treatment with anti-diarrhoeals within 7 days prior to randomisation.
  • •(10) Treatment with nicotine patch within 7 days prior to randomisation.
  • •(11) Received any investigational drug within 30 days prior to randomisation.
  • •(12) History of colectomy or partial colectomy.
  • •(13) History of definite dysplasia in colonic biopsies.
  • •(14) Crohn’s disease.
  • •(15) Immediate or significant risk of toxic megacolon.
  • •(16) Known bleeding disorders.
  • •(17) Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
  • •(18) Serum creatinine > 1.5 times the upper limit of the normal range.
  • •(19) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
  • •(20) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
  • •(20) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject’s ability to fully participate in the study.
  • •(21) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
  • •(22) Stools positive for Clostridium difficile toxin.
  • •(23) Pregnant or lactating women.
  • •(24) Prior enrolment in the study.
  • •(1) Withdrawal from the induction phase prior to the Week 8 visit.

Investigators

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