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NCT00063414 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
NCT00063414 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals.
The verdict
NCT00063414, 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 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.
Interventions
- DRUG Alicaforsen
Trial Details
| Field | Value |
|---|---|
| Start Date | 2002-11-20 |
| Est. Completion | 2005-03-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063414
The ClinicalTrials.gov registry entry for NCT00063414 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.
NCT00063414 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00063414 about?
NCT00063414 is a clinical study titled "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". 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,...
What is the current status of trial NCT00063414?
This trial is currently completed. It is a Phase 2 study. The study started on 2002-11-20. Estimated completion is 2005-03-24.
What interventions are being tested in trial NCT00063414?
The interventions under investigation include: Alicaforsen (DRUG).
Who is sponsoring clinical trial NCT00063414?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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