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Colitis, Ulcerative clinical trials

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NCT ID: NCT01903252 Completed - Clinical trials for Acute Ulcerative Colitis

TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)

Precision-UC
Start date: July 2013
Phase: Phase 3
Study type: Interventional

The purpose of this research study was to compare the medication TP05 to the medication Asacol™ for the treatment of ulcerative colitis (UC) and to assess the safety and tolerability of TP05. This study investigated whether TP05 is as good as (non-inferior to) Asacol™(1). (1)The trademark Asacol™ is registered in over 55 countries as Asacol™ and as Octasa™, Fivasa™, Lixacol™, Asacolon™ in the United Kingdom, France, Spain and Ireland, respectively. The rights to Asacol, including the rights to the trademark, are owned by Tillotts Pharma AG in various countries except for the following: Switzerland, USA, United Kingdom, Canada, Italy, Belgium, the Netherlands and Luxembourg.

NCT ID: NCT01900574 Completed - Colitis, Ulcerative Clinical Trials

A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

Start date: August 9, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

NCT ID: NCT01896635 Completed - Ulcerative Colitis Clinical Trials

Faecal Microbiota Transplantation in Ulcerative Colitis

FOCUS
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial

NCT ID: NCT01891214 Completed - Ulcerative Colitis Clinical Trials

Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease

F-IBDQ
Start date: December 2013
Phase: N/A
Study type: Observational

The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

NCT ID: NCT01882764 Terminated - Ulcerative Colitis Clinical Trials

HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis

NATRUL-4
Start date: June 2013
Phase: Phase 3
Study type: Interventional

A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.

NCT ID: NCT01882426 Terminated - Ulcerative Colitis Clinical Trials

Care Path for the Management of Ulcerative Colitis

CONSTRUCT
Start date: May 2014
Phase: Phase 4
Study type: Interventional

Assess if standardized care-path that features objective evaluations of disease activity and time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.

NCT ID: NCT01882205 Recruiting - Ulcerative Colitis Clinical Trials

Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

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

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques. Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system. These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.

NCT ID: NCT01880918 Recruiting - Lymphoma Clinical Trials

A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

Start date: October 2012
Phase: N/A
Study type: Observational

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

NCT ID: NCT01877577 Completed - Clinical trials for Ulcerative Colitis (UC)

Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

Start date: April 2012
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them. Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.

NCT ID: NCT01863771 Completed - Colitis, Ulcerative Clinical Trials

A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese participants with moderately to severely active ulcerative colitis.