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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: Completed Phase 2 study, sponsored by Ionis Pharmaceuticals.
NCT00063414 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00063414 record still lists
NCT00063414 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Alicaforsen is the first listed.
NCT00063414 does not publish any study locations in the registry export this page uses.
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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