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NCT01160822 · ClinicalTrials.gov registry record · Phase 2
To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT01160822: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01160822 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160822, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
Primary Outcome
An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseli
Interventions
- DRUG Naproxen
- BIOLOGICAL Canakinumab
- DRUG Placebo to canakinumab
- DRUG Placebo to Naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT01160822 record still lists
NCT01160822 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 4 interventions - of which Naproxen is the first listed.
NCT01160822 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160822 about?
NCT01160822 is a clinical study titled "To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee". The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
What is the current status of trial NCT01160822?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2010-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01160822?
The interventions under investigation include: Naproxen (DRUG), Canakinumab (BIOLOGICAL), Placebo to canakinumab (DRUG), Placebo to Naproxen (DRUG).
Who is sponsoring clinical trial NCT01160822?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01160822's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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