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A Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX507-H in Healthy Male and Female Subjects

Primary:to evaluate the safety and tolerability of single oral doses of CCX507-H, over a range of 3 dose levels, in healthy male and female subjectsSecondary:to evaluate the following:* Single dose pharmacokinetic profile (PK) of CCX507-H over a…

A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohnâ¤*s Disease

Primary: to assess the efficacy of GSK1605786A compared with placebo as an induction therapy in subjects with moderately-to-severely active Crohn*s disease over 12 weeks. Secondary: Safety, quality of life, healthcare resource utilisation, PK,…

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:
A Double-blind, Randomized Placebo-controlled Pilot Study

1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, size and rate of dysplasia, relative to the placebo group. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA…

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Primary: assess the effect of tralokinumab compared with placebo in patients with active ulcerative colitis by assessment of clinical response, as defined by the Mayo score, at week 8.Other objectives: assess the change in (partial) Mayo scores…

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT)

Primary Objective* To characterize the dose-response and efficacy of PF-00547659 in inducing clinical remission based upon Mayo Score in subjects with moderate to severe ulcerative colitis.Secondary Objectives* To evaluate the induction of clinical…

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Primary Objective• To demonstrate the efficacy of tofacitinib as maintenance therapy in subjects with UC. Secondary Objectives• To evaluate the safety and tolerability of tofacitinib as maintenance therapy in subjects with UC.• To evaluate the…

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical response at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn*s Disease

Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…

A randomized double-blind, placebo-controlled, parallel group clinical study of pregabalin in patients with chronic pancreatitis

The effect of pregabalin treatment on patients with chronic pancreatitis

A phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn's Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Primary ObjectivesPlacebo-Controlled Induction Period: Primary Objective: Compare the proportion of subjects who have a clinical response (as defined by a reduction in Crohn*s Disease Activity Index [CDAI] >= 100 or an absolute CDAI score…

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Placebo-Controlled Induction Period Primary Objective: Compare the proportion of subjects who have a clinical response at Week 12 between the abatacept and placebo treatment regimens.Maintenance Period Primary Objective: Compare the proportion of…

Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn*s Disease.

Primary objective of the study is to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d. for 8 consecutive weeks, to induce complete healing of mucosal ulcerations of ileum and/or colon, assessed by endoscopy,Secondary…

Effect of CAlcium on intestinal PErmeability and Diarrhea in Ulcerative Colitis

PRIMARY• To investigate whether calcium supplementation, in addition to standard induction therapy, decreases intestinal permeability (Chroom EDTA) in patients with active ulcerative colitis.• To observe whether calcium supplementation, in addition…

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:
A Double-blind, Randomized Placebo-controlled Pilot Study

1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment with these agents on ACF number, size and rate of dysplasia. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by…

A Multi-Center, Randomized, Double-Blind, Placebo ??? Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.

To demonstrate the efficacy of adalimumab on mucosal healing in subjects with moderate to severe ileocolonic Crohn's disease and to delineate the safety of adalimumab when administered to subjects with Crohn's disease.

A randomized, double-blinded, placebo controlled, prospective, clinical phase II study to assess the safety and efficacy of expanded allogeneic adipose-derived stem cells (ASCs) for the treatment of complex perianal fistulas in Crohn???s disease.

To assess the safety (incidence of drug-related adverse events) and efficacy of allogeneic ASCs for the treatment of complex perianal Crohn*s fistulas compared to placebo.

A controlled, randomised, double-blind, multicenter study, comparing methotrexate vs placebo in steroid-refractory ulcerative colitis

This multicenter, prospective, controlled, randomized, double-blind study aims at provingthat the success level measured by steroid-free remission in patients with steroiddependentulcerative colitis (UC) is higher with methotrexate than with placebo…

A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn*s Disease

The purpose of this study is to evaluate the safety and effectiveness of adalimumab for the treatment of moderate to severe Crohn*s disease in children between 6-17 years of age. In addition, information will be collected to select the most…

A double-blind, randomised, placebo-controlled multicenter study to asses the safety and efficacy of AST-120 in mild to moderately active Crohn's patients with fistulas.

The primary efficacy endpoint is treatment success in the therapy for mild to moderate Crohn*s disease with fisultas defined by: - A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE

Primary objectiveThe primary objective of the study is to estimate the effects of tofacitinib in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn*s disease previously achieving clinical response or…