TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
Condition: Acute Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: TP05; Asacol 400 mg
Intervention description: 3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label); 3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label)
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 817.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: UC

Summary:

      The purpose of this research study was to compare the medication TP05 to the medication
      Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and
      tolerability of TP05. This study investigated whether TP05 is as good as (non-inferior to)
      Asacol™(1).

      (1)The trademark Asacol™ is registered in over 55 countries as Asacol™ and as Octasa™,
      Fivasa™, Lixacol™, Asacolon™ in the United Kingdom, France, Spain and Ireland, respectively.
      The rights to Asacol, including the rights to the trademark, are owned by Tillotts Pharma AG
      in various countries except for the following: Switzerland, USA, United Kingdom, Canada,
      Italy, Belgium, the Netherlands and Luxembourg.
    

Eligibility criteria:

        Induction phase - Main criteria for inclusion include:

          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.

          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.

        Induction Phase - Main criteria for exclusion include:

        Subjects who exhibit any of the following conditions are to be excluded from the study:

        (1) Severe UC defined by the following criteria: 6 bloody stools daily with one or more of
        the following:

          -  a. oral temperature > 37.8 degrees C or > 100.0 degrees F

          -  b. pulse > 90 beats/min

          -  c. haemoglobin < 10 g/dL (2) Treatment with oral mesalamine at a dose of > 2.4 g/day
             within 4 weeks prior to randomisation.

             (3) Treatment with topical therapy (mesalamine or corticosteroids) within 2 weeks
             prior to randomisation (4) Treatment with systemic or rectal steroids within 4 weeks
             prior to randomisation.

             (5) Treatment with immunosuppressants within 6 weeks prior to randomisation. (6)
             Treatment with infliximab or other biologics within 3 months prior to randomisation.

             (7) Treatment with antibiotics within 7 days prior to randomisation. (8) Treatment
             with probiotics within 7 days prior to randomisation. (9) Treatment with
             anti-diarrhoeal treatment 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 mesalazine. (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) 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.

        OLE - Main criteria for inclusion include:

          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.

        OLE - Main criteria for exclusion include:

        (1) Withdrawal from the induction phase prior to the Week 8 visit.