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Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

2014-07-23 22:00:36 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Description

This study will be a double-blind, randomized, parallel-group, active comparator design.

Twenty-four patients with knee osteoarthritis (OA) will be randomized to be treated with a single IA injection of 10, 40, or 60 mg of FX006 or 40 mg of commercially available triamcinolone acetonide.

Each patient will be evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics will be evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoarthritis of the Knee

Intervention

FX006, commercially available triamcinolone acetonide

Location

Adelaide
South Australia
Australia

Status

Completed

Source

Flexion Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T22:00:36-0400

Clinical Trials [1952 Associated Clinical Trials listed on BioPortfolio]

Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes

This study is a double-blind, randomized, parallel group comparison of the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, USP (referred to as TCA IR in the protocol) o...

Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension...

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Proof of Concept Study Comparing FX006 to Kenalog®-40 in Active Military and Medically Retired Patients With Post-Traumatic Osteoarthritis of the Knee

This study is a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in active military and...

Study to Characterize the Systemic PK and Local Extent and Duration of Exposure of TCA From FX006 in Patients With OA of the Knee

This is an open-label, single administration study of 40 mg of FX006 conducted in male and female patients with Osteoarthritis (OA) of the knee.

PubMed Articles [1752 Associated PubMed Articles listed on BioPortfolio]

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study.

Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation...

Do These Crystals Really Sparkle?: Commentary on an article by Philip G. Conaghan, MBBS, PhD, FRACP, FRCP, et al.: "Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain. A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study".

Suprachoroidal Space Alterations Following Delivery of Triamcinolone Acetonide: Post-Hoc Analysis of the Phase 1/2 HULK Study of Patients With Diabetic Macular Edema.

To study anatomic changes in the suprachoroidal space (SCS) following suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension.

Intralymphatic histiocytosis treated with intralesional triamcinolone acetonide and pressure bandage.

Intralymphatic histiocytosis is a rare disorder associated with a variety of inflammatory conditions. We report the case of an 89-year-old woman with a history of a right knee replacement and a ruptur...

Treatment duration and side effect profile of long-term use of intravitreal preservative-free triamcinolone acetonide in uveitis.

Non-infectious uveitis has been treated historically with corticosteroid therapy in varying doses and routes. Triesence, a preservative-free sterile formulation of triamcinolone acetonide, has been us...

Medical and Biotech [MESH] Definitions

An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

A region of the lower extremity immediately surrounding and including the KNEE JOINT.

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