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Ulcerative Colitis clinical trials

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NCT ID: NCT00713310 Completed - Ulcerative Colitis Clinical Trials

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis

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

The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.

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: 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: 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: NCT00663819 Terminated - Ulcerative Colitis Clinical Trials

Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

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

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

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.