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Ulcer clinical trials

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NCT ID: NCT00063830 Completed - Ulcerative Colitis Clinical Trials

ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.

Start date: April 3, 2003
Phase: Phase 2
Study type: Interventional

This is a multi-center trial in the US and Europe to test the safety, efficacy and tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a specific protein, called ICAM-1, a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis. The ISIS 2302-CS27 study will compare four dosing regimens and determine the minimum effective dose of alicaforsen enema in UC patients over six weeks as compared to a placebo enema. (The probability of receiving active formulation is 4:1). The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.

NCT ID: NCT00063414 Completed - Ulcerative Colitis Clinical Trials

ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis

Start date: November 20, 2002
Phase: Phase 2
Study type: Interventional

This is a multi-center trial to test the safety, efficacy and tolerability of alicaforsen (ISIS 2302), a new type of drug called an antisense drug, in patients with mild to moderate active Ulcerative Colitis (UC). Alicaforsen is designed to reduce the production of a specific protein, called ICAM-1, a substance that plays a significant role in the increase of inflammation and is likely to be involved in inflammatory bowel diseases such as ulcerative colitis. The ISIS 2302-CS22 study will examine the effects of one of two dosages of alicaforsen delivered by enema over a six-week period as compared to an active control, mesalamine enema (The probability of receiving the alicaforsen formulation is 2:1). The primary objective of this study is to evaluate the percentage reduction in DAI at Week 6.

NCT ID: NCT00061633 Completed - Burns Clinical Trials

Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

FAST
Start date: June 2003
Phase: Phase 2
Study type: Interventional

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

NCT ID: NCT00048347 Completed - Ulcerative Colitis Clinical Trials

Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis

Start date: October 2002
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX) in treating ulcerative colitis and examine the drug's effect on the immune system. People with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by immune cells in the lining of the colon. Studies have shown that interferon-beta may block the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord. Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may be eligible for this study. Candidates will be screened with a review of their medical records, a medical history and physical examination, electrocardiogram (EKG), blood, urine, and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will also be done to determine disease activity and extent. This test uses a lighted tube to examine the amount of inflammation in the colon and take tissue samples (biopsies) for testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the intestinal mucosa and project an image of the inner lining of the intestine onto a TV monitor. At various places in the intestine, small pieces of tissue are plucked out by a special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1 hour. Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical examination, and blood tests. Patients whose colitis has not worsened at the end of the 4 weeks and who have not had significant drug side effects will continue to receive weekly injections for an additional 8 weeks. Some patients may receive some of the last eight injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to 4 weeks for a physical exam, symptoms check and blood tests. After the 12 injections are completed, patients will have another colonoscopy to evaluate the response to treatment and will return to the Clinical Center every 6 weeks for a total of four visits, for a physical examination, symptoms check and blood tests.

NCT ID: NCT00040495 Completed - Clinical trials for Peptic Ulcer Hemorrhage

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Start date: April 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.

NCT ID: NCT00037570 Completed - Clinical trials for Peptic Ulcer Hemorrhage

Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Start date: November 2000
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.

NCT ID: NCT00036439 Completed - Ulcerative Colitis Clinical Trials

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

Start date: February 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.

NCT ID: NCT00033943 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

Start date: January 2001
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.

NCT ID: NCT00032305 Completed - Ulcerative Colitis Clinical Trials

Research Study in Patients With Severe Ulcerative Colitis

Start date: March 2002
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

NCT ID: NCT00013286 Completed - Clinical trials for Diabetic Foot Ulcers

A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk

Start date: October 1999
Phase: Phase 2
Study type: Observational

This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation. In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.