Will The Real Psychology Of Crohn's Disease Please Stand Up?
The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.
NCT01573078 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01573078/
A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
NCT01466374 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01466374/
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).
NCT01442363 — Perianal Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/perianal-crohn-s-disease/NCT01442363/
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.
NCT01318993 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01318993/
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 Crohn's Disease
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.
NCT01316939 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01316939/
Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
Primary objective: Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids. Secondary objectives: 1. safety of EryDex 2. emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients; 3. duration of the period of remission; 4. evaluation of the hypophysis-adrenal function; 5. study of plasma concentrations of dexamethasone; 6. effect of therapy on the metabolism of calcium and on indexes of inflammation; 7. assessing the quality of life; 8. rate of surgical resection 9. evaluation of the indirect costs of care.
NCT01277289 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01277289/
A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.
NCT01245088 — Crohn's Disease
Status: Withdrawn
http://inclinicaltrials.com/crohn-s-disease/NCT01245088/
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
NCT01070303 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01070303/
A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection
The purpose of this study is to see whether T2 versus Azathioprine is able to maintain the clinical and endoscopic remission in subjects with Crohn's disease after surgery-induced remission. The side effects related to T2 and AZA will also be monitored throughout the study.
NCT01015391 — Crohn's Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-s-disease/NCT01015391/
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
Objectives: The primary objective of the study was 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, in patients with endoscopic and clinical evidence of active moderate-to-severe Crohn's disease not controlled by conventional therapies. The secondary objectives of the study were: - to evaluate the effect of ITF2357 on endoscopic disease activity assessed using both the Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score of Crohn's Disease (SES-CD); - to evaluate the effect of ITF2357 on clinical disease activity, assessed using the Crohn's Disease Activity Index (CDAI); - to assess the safety and tolerability of ITF2357; to assess the pharmacokinetic profile of ITF2357.
NCT00792740 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT00792740/