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NCT00819585 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 432
- Enrollment target
NCT00819585 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 432 participants.
The verdict
NCT00819585, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 432 participants
- Enrollment target
Study Summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Interventions
- DRUG Canakinumab
- DRUG Colchicine
- DRUG Allopurinol
- DRUG Placebo Matching Canakinumab
- DRUG Placebo Matching Colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00819585
The ClinicalTrials.gov registry entry for NCT00819585 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 432 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Canakinumab is the first listed.
NCT00819585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00819585 about?
NCT00819585 is a clinical study titled "A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)". The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label...
What is the current status of trial NCT00819585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 432 participants. The study started on 2008-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00819585?
The interventions under investigation include: Canakinumab (DRUG), Colchicine (DRUG), Allopurinol (DRUG), Placebo Matching Canakinumab (DRUG), Placebo Matching Colchicine (DRUG).
Who is sponsoring clinical trial NCT00819585?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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