CLINICAL TRIALS PROFILE FOR ZILRETTA
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All Clinical Trials for ZILRETTA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02116972 ↗ | Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee | Completed | Flexion Therapeutics, Inc. | Phase 2 | 2014-04-01 | The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control). |
| NCT02357459 ↗ | Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee | Completed | Flexion Therapeutics, Inc. | Phase 3 | 2015-01-01 | The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee. |
| NCT02468583 ↗ | Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee | Terminated | Flexion Therapeutics, Inc. | Phase 2 | 2015-02-01 | This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee. |
| NCT02637323 ↗ | Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee | Completed | Flexion Therapeutics, Inc. | Phase 2 | 2015-11-01 | The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee. |
| NCT02762370 ↗ | Study to Assess the Effects of FX006 on Blood Glucose in Patients With OA of the Knee and Type 2 Diabetes | Completed | Flexion Therapeutics, Inc. | Phase 2 | 2016-04-01 | The purpose of this study was to compare the effects of FX006 and Triamcinolone Acetonide Injectable Suspension, United States Pharmacopeia (USP) (referred to as TCA IR in the protocol) on blood glucose (BG) in patients with osteoarthritis (OA) of the knee and Type 2 diabetes mellitus (DM). |
| NCT03378076 ↗ | Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA | Completed | Flexion Therapeutics, Inc. | Phase 2 | 2017-12-06 | 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. |
| NCT03382262 ↗ | Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip | Completed | Flexion Therapeutics, Inc. | Phase 2 | 2017-12-18 | 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) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ZILRETTA
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