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Colitis clinical trials

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NCT ID: NCT00702611 Terminated - Ulcerative Colitis Clinical Trials

Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis

ATICCA
Start date: June 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients

NCT ID: NCT00694980 Completed - Ulcerative Colitis Clinical Trials

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

Start date: September 2008
Phase: Phase 1
Study type: Interventional

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

NCT ID: NCT00679432 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.

NCT ID: NCT00679380 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Start date: June 2008
Phase: Phase 3
Study type: Interventional

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

NCT ID: NCT00676832 Completed - Colitis, Ulcerative Clinical Trials

Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

Start date: May 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.

NCT ID: NCT00659867 Terminated - Ulcerative Colitis Clinical Trials

Endomicroscopy in Ulcerative Colitis

Start date: December 2008
Phase: N/A
Study type: Interventional

This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.

NCT ID: NCT00659802 Completed - Ulcerative Colitis Clinical Trials

Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

Start date: February 7, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.

NCT ID: NCT00656890 Completed - Ulcerative Colitis Clinical Trials

A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

MDX1100-06
Start date: April 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.

NCT ID: NCT00652145 Completed - Ulcerative Colitis Clinical Trials

Dose Escalation and Remission (DEAR)

DEAR
Start date: September 2008
Phase: Phase 4
Study type: Interventional

The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.

NCT ID: NCT00643071 Completed - Ulcerative Colitis Clinical Trials

Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Start date: September 2006
Phase: Phase 3
Study type: Interventional

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.