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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > 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  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
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
For Condition: Ulcerative Colitis
Status: No longer recruiting
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria Patients must meet the following criteria at screening to be eligible for enrollment: - Age greater than or equal to 18 years - Diagnosis of ulcerative colitis of at least 6 months duration - Current left-sided flare, defined as activity in the colon 5-50 cm from the anal verge, extending at least 15 cm proximal to the anal verge and confirmed by endoscopic evaluation within 14 days of baseline visit. - Baseline DAI score of 4-10 including abnormal endoscopic score - On at least one or more of the following treatments for ulcerative colitis prior to baseline visit: a. Stable background oral mesalamine therapy for greater than or equal to 30 days, and/or b. Stable background mercaptopurine for greater than or equal to 60 days prior to baseline, and/or c. Stable azathiprine therapy for greater than or equal to 60 days prior to baseline - Written informed consent prior to performing screening evaluations. Exclusion criteria Patients who meet any of the following criteria at screening are not eligible for enrollment: - Bowel stricture, toxic megacolon, colonic dysplasia, adenoma or carcinoma - Uncontrolled hematologic, renal, hepatic, metabolic, psychiatric, CNS, pulmonary or cardiovascular disease, or sufficient level of disease that could interfere with the patient's ability to comply with protocol participation - Enteric pathogens or presence of Clostridium difficile toxin in stool - History of colon resection - Major surgical procedure within one month of baseline visit - Steroid or mesalamine enema within 14 days of baseline visit - Systemic steroids (including ACTH) within 30 days of baseline visit - Tumor necrosis factor-alpha (TNF-α) inhibitor treatment within 90 days of baseline visit - Non-steroidal anti-inflammatory agents (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, within 14 days of baseline visit - Methotrexate, cyclosporin or thalidomide within 90 days of baseline visit - Any active infection currently requiring treatment - Malignancy within 5 years except for squamous cell or basal cell cancers of the skin - Current infectious, ischemic, or immunological disease with gastrointestinal involvement - ISIS 2302 treatment within 12 months of baseline visit - History of allergy to mesalamine - Treatment with an investigational or off-label drug within 90 days of screening or currently in long-term follow up for another investigational treatment protocol
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: ISIS 2302-CS22;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063414
Other Ulcerative Colitis Studies:
1. FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
2. Study of Infliximab for the treatment of patients with active Ulcerative Colitis.
3. FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
4. Quality of Life in Pediatric Inflammatory Bowel Disease
5. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Illinois Clinical Trials
Other Chicago 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
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