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NCT01356602 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
A Phase 3 study of Acute Gouty Arthritis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
- 20
- Study locations
NCT01356602: Completed Phase 3 study of Acute Gouty Arthritis, sponsored by Novartis Pharmaceuticals.
NCT01356602 is a Phase 3 study of Acute Gouty Arthritis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 397 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356602, a Phase 3 study of Acute Gouty Arthritis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Primary Outcome
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Triamcinolone Acetonide
- DRUG Canakinumab pre-filled syringe
- DRUG Canakinumab lyophilized powder
Study Locations (20)
California
- Novartis Investigative Site - Buena Park
- Novartis Investigative Site - Fair Oaks
- Novartis Investigative Site - Norwalk
- Novartis Investigative Site - Orangevale
- Novartis Investigative Site - Pasadena
- Novartis Investigative Site - Westlake Village
Florida
- Novartis Investigative Site - Clearwater
- Novartis Investigative Site - Jupiter
- Novartis Investigative Site - Largo
- Novartis Investigative Site - South Miami
Alabama
- Novartis Investigative Site - Anniston
- Novartis Investigative Site - Gulf Shores
- Novartis Investigative Site - Mobile
Arizona
- Novartis Investigative Site - Chandler
- Novartis Investigative Site - Phoenix
- Novartis Investigative Site - Scottsdale
Georgia
- Novartis Investigative Site - Augusta
- Novartis Investigative Site - Decatur
Idaho
- Novartis Investigative Site - Meridian
Kansas
- Novartis Investigative Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01356602 record still lists
NCT01356602 is an interventional study that assigns participants to a tested intervention. The registered 397 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Acute Gouty Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01356602 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01356602 about?
NCT01356602 is a clinical study titled "Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients". This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
What is the current status of trial NCT01356602?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2011-05. Estimated completion is 2012-09.
What conditions does trial NCT01356602 study?
This clinical trial studies the following conditions: Acute Gouty Arthritis.
What interventions are being tested in trial NCT01356602?
The interventions under investigation include: Placebo (DRUG), Triamcinolone Acetonide (DRUG), Canakinumab pre-filled syringe (DRUG), Canakinumab lyophilized powder (DRUG).
Who is sponsoring clinical trial NCT01356602?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01356602 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01356602's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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