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Colitis, Ulcerative clinical trials

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NCT ID: NCT00708656 Completed - Ulcerative Colitis Clinical Trials

The Colitis Once Daily Asacol Study

CODA
Start date: October 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of dosing mesalazine 800 mg tablets (Asacol®) at 2.4 g once daily versus divided doses three times daily in the maintenance of remission of ulcerative colitis.

NCT ID: NCT00705484 Completed - Ulcerative Colitis Clinical Trials

European Safety Registry in Ulcerative Colitis (P04808)

OPUS
Start date: June 1, 2007
Phase:
Study type: Observational

This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).

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: NCT00679003 Completed - Ulcerative Colitis Clinical Trials

Managing Inflammatory Bowel Disease

Managing IBD
Start date: September 2007
Phase: N/A
Study type: Interventional

Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.

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: 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.