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Sponsored by: |
Isis Pharmaceuticals |
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Information provided by: | Isis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00063414 |
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.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Alicaforsen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare) |
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-CS22 |
Study First Received: | June 25, 2003 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00063414 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Immunologic Factors Gastrointestinal Diseases Ulcer Colonic Diseases ISIS 2302 |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Immunosuppressive Agents Colitis |
Immunologic Factors Gastrointestinal Diseases Ulcer Physiological Effects of Drugs Colonic Diseases Gastrointestinal Agents Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Immunosuppressive Agents Pharmacologic Actions Digestive System Diseases Pathologic Processes Therapeutic Uses ISIS 2302 Gastroenteritis Colitis |