Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01080131 · ClinicalTrials.gov registry record · Phase 3
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
NCT01080131 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 226 participants.
The verdict
NCT01080131, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357. The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.
Interventions
- DRUG Canakinumab 150 mg
- DRUG Triamcinolone acetonide 40 mg
- DRUG Placebo to canakinumab
- DRUG Placebo to triamcinolone acetonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01080131
The ClinicalTrials.gov registry entry for NCT01080131 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 226 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 4 interventions - of which Canakinumab 150 mg is the first listed.
NCT01080131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01080131 about?
NCT01080131 is a clinical study titled "Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.". The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, n...
What is the current status of trial NCT01080131?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2010-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01080131?
The interventions under investigation include: Canakinumab 150 mg (DRUG), Triamcinolone acetonide 40 mg (DRUG), Placebo to canakinumab (DRUG), Placebo to triamcinolone acetonide (DRUG).
Who is sponsoring clinical trial NCT01080131?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.