Active clinical trials for "Colitis"

Several open-label studies reported thalidomide efficacy in inducing clinical remission and steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in children. This is a randomized placebo controlled (RCT) double blind study, to evaluate the efficacy of thalidomide in inducing clinical remission at 8 weeks in refractory IBD patients aged 2-20 years. The primary hypotheses of the study is that thalidomide would be more effective than placebo in inducing clinical remission. The RCT phase is followed by a open-label phase, to further evaluate efficacy and safety of thalidomide in thalidomide responders, with a total follow up of one year.

The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

PHASE: II TYPE OF STUDY : With direct benefit DESCRIPTIVE: Multicenter, randomized, double-blind study INCLUSION CRITERIA: Steroid-dependent ulcerative colitis OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients INCLUSION PERIOD: 24 months STUDY DURATION: 36 months EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.

The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial

The primary objectives of this study are as follows: To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.

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.