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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. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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. Clinical research trials and 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. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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.. 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. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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. clinical trial. Test subjects typically receive the most expert healthcare available for their 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. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > 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.  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.
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.
For Condition: Ulcerative Colitis
Status: No longer recruiting
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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.
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 left-sided 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 - Patients with pancolitis - 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 - 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-CS27;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063830
Other Ulcerative Colitis Studies:
1. 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
2. Quality of Life in Pediatric Inflammatory Bowel Disease
3. Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
4. Study of Infliximab for the treatment of patients with active Ulcerative Colitis.
5. Interferon-beta Treatment of Ulcerative Colitis
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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.
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