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Colitis, Ulcerative clinical trials

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NCT ID: NCT01004185 Terminated - Ulcerative Colitis Clinical Trials

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

CAMPIII
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.

NCT ID: NCT01002287 Terminated - Ulcerative Colitis Clinical Trials

An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

Start date: October 2009
Phase: N/A
Study type: Interventional

This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.

NCT ID: NCT00984568 Terminated - Colitis, Ulcerative Clinical Trials

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

MUNIX
Start date: November 2009
Phase: Phase 3
Study type: Interventional

This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine (AZA) with a more intensive and early "Top-Hold" approach with intravenous infliximab (5 mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.

NCT ID: NCT00979485 Terminated - Ulcerative Colitis Clinical Trials

Microparticles in Pediatric Inflammatory Disease

Start date: August 2009
Phase: N/A
Study type: Observational

The purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (IBD). The hypothesis is that circulating microparticles will be higher in children with active IBD, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.

NCT ID: NCT00968721 Terminated - Ulcerative Colitis Clinical Trials

Decisional Influences and Inflammatory Bowel Disease (IBD) Patients' Medication Use

Start date: June 2010
Phase: N/A
Study type: Observational

The primary purpose of this study is to pilot test an instrument that the investigators will develop to assess decision influences on inflammatory bowel disease patients' medication adherence decision-making. This pilot study will use an exploratory, descriptive cross-sectional survey approach to pilot test the instrument and answer the research questions. The main hypothesis is that patients at risk for intentionally modifying their prescribed medication regimen will differ on influences on decision-making, health status, and utilization of the IBD clinic services compared to those who are intentionally adherent and who continue adherence over time.

NCT ID: NCT00947674 Terminated - Ulcerative Colitis Clinical Trials

A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)

Start date: May 2009
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.

NCT ID: NCT00837304 Terminated - Ulcerative Colitis Clinical Trials

Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis

Start date: January 2009
Phase: N/A
Study type: Observational

The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon. Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy. The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.

NCT ID: NCT00805285 Terminated - Ulcerative Colitis Clinical Trials

The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis

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

The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).

NCT ID: NCT00790478 Terminated - Ulcerative Colitis Clinical Trials

Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Ulcerative colitis is an inflammatory bowel disease that afflicts up to one million people in the U.S. Symptoms include rectal urgency, bloody diarrhea, moderate to severe abdominal pain, fever, and fatigue. Melatonin is a hormone that is associated with sleep and other body functions that may be related to health. Melatonin is produced in the pineal gland and, in fact, it is produced in even greater amounts in the gut. Melatonin appears to be important in gastrointestinal tract physiology and health, and data from cell and animal experiments, and some studies in humans, suggest that supplemental melatonin may help ameliorate colitis. Given that current treatments for ulcerative colitis are not always effective, and often have serious side effects, there is considerable interest in finding alternative treatments for this disease. However, experimental data on the ability of melatonin to improve ulcerative colitis in humans are lacking. To address this, we plan to conduct a pilot clinical trial (60 adult male and female participants) that will obtain preliminary data about the effectiveness of melatonin supplementation as a treatment for ulcerative colitis in adult men and women with the disease. The "Melatonin and Ulcerative Colitis" study funded by a grant from the Broad Foundation's Broad Medical Research Program (http://www.broadmedical.org).

NCT ID: NCT00751933 Terminated - Ulcerative Colitis Clinical Trials

Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

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

Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.