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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn*s Disease

The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease.- To evaluate the safety of IV induction regimens of…

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine

Primary:• To prove the superiority of a 12-week add-on treatment with 3.2 g/daygastro-resistant phosphatidylcholine granules (LT-02) in at least one of twodifferent dosing regimens versus LT-02 placebo for the induction ofremission in patients with…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

INDUCTION STUDY Primary Objectives:* To evaluate the efficacy of intravenous (IV) ustekinumab in inducing clinical remission in subjects with moderately to severely active UC.* To evaluate the safety of IV ustekinumab in subjects with moderately to…

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Primary:* To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.Secondary:* To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.* To evaluate the effect of…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy

The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…

The effect of Caphosol on the development of esophagitis in (N)SCLC patients treated with concurrent chemo/radiotherapy

Trial hypothesisAdding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the…

Lengthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study.

To assess the safety of lengthening the adalimumab dosing interval from 2 to 3 weeks, in patients with Crohn*s disease or ulcerative colitis in long term (6 months) remission.

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

Evaluate the efficacy of the combination therapie with azithromycin and metronidazole in a randomized trial

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

Primary Objective * To demonstrate the efficacy of tofactitinib in inducing remission in subjects with moderately to severely active UC. Secondary Objectives * To evaluate the safety and tolerability of tofactitinib in subjects with moderately to…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohnâ¤*s Disease

Primary: to assess the efficacy of GSK1605786A compared with placebo in maintaining remission. Secondary: Safety, quality of life, healthcare resource utilisation, work productivity.

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn*s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Primary ObjectiveThe primary objective of this study will be to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic…

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment

Ulcerative colitis is an inflammatory disease that affects the colon. The extent and severity of the disease may vary: it is possible that the disease only the rectum (the lower part of the colon) found, but the disease may extend over the entire…

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,…

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…

Hypnotherapy for adolescents and adults with inflammatory bowel disease and symptoms compatible with irritable bowel syndrome

To study the effectiveness of gut-directed hypnotherapy in the treatment of IBS-like symptoms in patients with inflammatory bowel disease.