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Ulcerative Colitis clinical trials

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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: NCT01861249 Terminated - Ulcerative Colitis Clinical Trials

Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658

NCT ID: NCT01805791 Terminated - Ulcerative Colitis Clinical Trials

A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

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

A placebo controlled study of two doses of HMPL-004 in patients 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. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.

NCT ID: NCT01742754 Terminated - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Ulcerative Colitis

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

Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.

NCT ID: NCT01716039 Terminated - Ulcerative Colitis Clinical Trials

Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.

NCT ID: NCT01706159 Terminated - Inflammation Clinical Trials

A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).

NCT ID: NCT01678911 Terminated - Ulcerative Colitis Clinical Trials

Efficacy of Gralise® for Chronic Pelvic Pain

Start date: August 2012
Phase: Phase 4
Study type: Interventional

This study is done to investigate the pain relieving effects of the study drug Gralise (a novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be recruited. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions, particularly in neuropathic pain. About 36 subjects will take part in this study.

NCT ID: NCT01659138 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis

FUSCIA
Start date: August 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658

NCT ID: NCT01567956 Terminated - Ulcerative Colitis Clinical Trials

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Start date: April 2012
Phase: Phase 3
Study type: Interventional

The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.