Ulcerative colitis drug trials

This study is the first-time-in-patient trial of GSK, a novel locally-acting anti-inflammatory compound, aimed at obtaining initial information on the tolerability, safety, pharmacokinetics including concentrations in colon mucosa and anti-inflammatory activity of GSK upon …. Rochester, MN. The Gardasil vaccine, a vaccine targeted towards the human papillomavirus HPV , has been shown to prevent the transmission of several strains of HPV in young women.

Women with inflammatory bowel disease IBD may not respond as well to this vaccine, either due to having IBD or due to immu…. ALTH for Ulcer. Oklahoma City, OK. The study will be conducted in two parts. The first part will be the assessment of the sa…. Los Angeles, CA. Patients with inflammatory bowel disease IBD will be assessed for immunologic response to pneumococcal vaccination.

Patients with IBD meet criteria as outlined by the Centers for Disease Control CDC for pneumococcal vaccination, yet the investigators have found that pneumococcal vaccin…. The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin FCP levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis.

HE for Colitis, Ulcerative. The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.

Golimumab 2 mg per kg for Colitis, Ulcerative. The purpose of this study is to assess the effects good and bad of golimumab CNTO therapy in participants with active ulcerative colitis UC sores in the colon. Golimumab 50 mg for Colitis, Ulcerative. The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously under the skin injections in maintenance therapy.

Golimumab mg for Colitis, Ulcerative. The purpose of this study is to assess the effects good and bad of golimumab CNTO therapy in participants with ulcerative colitis UC. MMX Mesalamine for Colitis. To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

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Participants were counted twice if the participant had both values that changed 'To Low' and 'To High'. Participants whose value was unchanged e. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Number of participants with Mayo endoscopic sub-score of 0 or 1 are presented. UCEIS total score was calculated by sum of all 3 sub-scale scores. Total score ranges from 0 to 8, with higher scores indicating more severe disease. BL is defined as the latest pre-dose assessment at Screening within 30 days prior to Day 1. Baseline is defined as the latest pre-dose assessment at Screening within 30 days prior to Day 1. BL is defined as the latest pre-dose assessment on Day 1.

Change from BL is the value at indicated time point minus BL value. MRS Score ranges from 0 to 7, with higher scores indicates more severity.

Score 0 indicates normal condition; 1 to 3 indicates mild condition; 4 to 6 indicates moderate condition and score 7 indicates severe condition. BL is defined as the latest pre-dose assessment. The most severe observation that the histopathologist sees on the slide is considered as the Geboes index total score, ranges from 0 to 5. BL is defined as the latest pre-dose assessment before Day 1. The Mayo scoring system ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease.

Scoring ranges from 0 to 9, higher scores indicating more severe disease. PK Population is defined as the participants in the safety population who received an active dose and for whom a GSK pharmacokinetic sample was obtained and analyzed Part A: Post-dose Plasma Concentrations of GSK [ Time Frame: Days 1 and 1, 2, 4 and 6 hours post dose ] Post-dose blood sample were collected on Days 1 and 43 at 1, 2, 4 and 6 hours for the measurement of plasma concentration of GSK Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Males: Male subjects with female partners of child bearing potential must comply with the contraception requirements. Females: A female subject is eligible to participate if she is not pregnant as confirmed by a negative serum human chorionic gonadotrophin hCG test , not lactating, and at least one of the following conditions applies:.

Non-reproductive potential defined as 1 Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy.

Females on hormone replacement therapy HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential FRP from 30 days prior to the first dose of study medication and until at least 2 days after the last dose of study medication and completion of the follow-up visit. The Investigator is responsible for ensuring that subjects understand how to properly use methods of contraception.

Hospitalization for treatment of infection within 60 days before first dose Day 1. Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria. Use of parenteral intravenous IV or intramuscular antibiotics antibacterials, antivirals, antifungals, or antiparasitic agents for an infection within 60 days before first dose. A history of opportunistic infections within 1 year of screening example: pneumocystis jirovecii, CMV pnemonitis, aspergillosis.

This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature. Recurrent or chronic infection or other active infection that, in the opinion of the Investigator might cause this study to be detrimental to the patient. History of tuberculosis TB , irrespective of treatment status.

In cases where the QuantiFERON or T-spot test is indeterminate, the subject may have the test repeated once, but they will not be eligible for the study unless the second test is negative. In cases where the QuantiFERON or T-spot test is positive, but a follow-up chest x-ray, locally read by a radiologist, shows no evidence of current or previous pulmonary tuberculosis, the subject may be eligible for the study at the discretion of the Investigator and GlaxoSmithKline GSK Medical Monitor.

Other medications including vitamins, herbal and dietary supplements will be considered on a case-by-case basis, and will be allowed if in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.

Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies GSK Study in Subjects With Ulcerative Colitis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Sensitivity and specificity for ulcer healing 2. Several oral mesalazine 5-ASA formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer.

Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day. This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease CD in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' pre-diet in terms of its ability to change the gut bacteria and fecal butyrate, an important short-chain fatty acid SCFA that limits bowel inflammation, a characteristic of this debilitating disease.

Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon.

Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells MSCs are a subset of adult stem cells residing in many tissues, including bone marrow BM , adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C.