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Ulcerative Colitis clinical trials

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NCT ID: NCT01375179 Terminated - Ulcerative Colitis Clinical Trials

Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis. The study will provide safety and tolerability data in this subject population up to eight weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a clinical response to KRP203 by following up responding subjects for an additional 12 weeks.

NCT ID: NCT01363453 Completed - Ulcerative Colitis Clinical Trials

User Surveillance in Ulcerative Colitis

CARE
Start date: October 2007
Phase: N/A
Study type: Observational

The aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are given.

NCT ID: NCT01349504 Completed - Ulcerative Colitis Clinical Trials

Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Start date: April 2011
Phase: N/A
Study type: Observational

Hypothesis: Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence. Objectives: To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence

NCT ID: NCT01346826 Completed - Ulcerative Colitis Clinical Trials

Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)

Start date: May 2011
Phase: Phase 4
Study type: Interventional

This study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.

NCT ID: NCT01341808 Completed - Ulcerative Colitis Clinical Trials

Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

NCT ID: NCT01340872 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

AEGIS-1
Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).

NCT ID: NCT01339273 Completed - Ulcerative Colitis Clinical Trials

Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

Start date: September 2011
Phase: N/A
Study type: Interventional

Laparoscopic (key-hole) large bowel resection is a minimally invasive procedure when compared to open large bowel resection, but is still associated with a significant amount of pain and discomfort. Analgesia is commonly provided by a multi-modal technique involving varying combinations of paracetamol, Non steroidal anti-inflammatory drugs (NSAIDs), regional analgesia and oral or parenteral opioids. While epidural analgesia is considered the gold standard for open colo-rectal procedures it can be associated with significant complications and may delay hospital discharge in laparoscopic procedures. Opioids are associated with an increased incidence of nausea, vomiting and sedation and reduced bowel motility which can also prolong recovery. Transversus Abdominis Plane (TAP) block is a technique which numbs the nerves carrying pain sensation from the abdominal wall and provides effective and safe analgesia with minimal systemic side effects. Their perceived benefits are thought to relate to reduced opioid consumption and therefore reduced opioid side effects. The investigators believe ultrasound guided TAP blocks will reduce pain and morphine consumption with a resultant improved patient satisfaction, earlier return of bowel function and earlier hospital discharge. The key research question the investigators are trying to answer is whether TAP block provide better pain relief than local anaesthetic infiltration of the laparoscopic port sites. Both techniques are currently being used in our hospital and a retrospective audit demonstrated better analgesia and lower consumption of morphine in the TAP block group.The differences were not statistically significant as the number patients in the audit were not large enough.The investigators are hoping that this study will demonstrate that the difference is real by recruiting the necessary number of patients into each group (36 per group)

NCT ID: NCT01336465 Completed - Ulcerative Colitis Clinical Trials

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

NCT ID: NCT01320436 Completed - Ulcerative Colitis Clinical Trials

Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis

5ASA
Start date: July 2011
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in patients. The current standard treatment for mild to moderate UC (MTMUC) includes 5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients continue to experience disease symptoms and flare-ups. These patients require higher dosages of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy which comprises higher risk of hazardous side effects. Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. In humans, a controlled study using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in maintaining remission in MTMUC patients . A small, preliminary open label study has also shown efficacy in reducing disease symptoms and inflammatory markers in this group of patients . This data provides bases for investigating an integrative approach to optimize the current standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA medication and curcumin could benefit this subgroup of patients and reduce morbidity and perhaps need for escalating pharmacological intervention.

NCT ID: NCT01320332 Completed - Ulcerative Colitis Clinical Trials

A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis

Start date: August 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.