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NCT00063830 · ClinicalTrials.gov registry record · Phase 2
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.
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
NCT00063830 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals.
The verdict
NCT00063830, a Phase 2 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
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.
Interventions
- DRUG Alicaforsen
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-04-03 |
| Est. Completion | 2004-10-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063830
The ClinicalTrials.gov registry entry for NCT00063830 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alicaforsen is the first listed.
NCT00063830 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00063830 about?
NCT00063830 is a clinical study titled "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.". 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 pr...
What is the current status of trial NCT00063830?
This trial is currently completed. It is a Phase 2 study. The study started on 2003-04-03. Estimated completion is 2004-10-11.
What interventions are being tested in trial NCT00063830?
The interventions under investigation include: Alicaforsen (DRUG).
Who is sponsoring clinical trial NCT00063830?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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