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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 is a Phase 3 study of Acute Gouty Arthritis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 397 participants. The trial reports 20 study locations across 7 states.

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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.

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

FieldValue
Enrollment Target 397 participants
Start Date 2011-05
Est. Completion 2012-09
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01356602

The ClinicalTrials.gov registry entry for NCT01356602 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 397 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 1 condition, with Acute Gouty Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01356602 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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