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Sponsored by: |
Isis Pharmaceuticals |
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Information provided by: | Isis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00063830 |
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.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Alicaforsen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must meet the following criteria at screening to be eligible for enrollment:
On at least one or more of the following treatments for ulcerative colitis prior to baseline visit:
Exclusion Criteria
Patients who meet any of the following criteria at screening are not eligible for enrollment:
Study ID Numbers: | ISIS 2302-CS27 |
Study First Received: | July 7, 2003 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00063830 |
Health Authority: | United States: Food and Drug Administration |
Ulcerative Colitis |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases ISIS 2302 |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions |