CLINICAL TRIALS PROFILE FOR FUNAPIDE
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Clinical Trials for Funapide
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT02068599 ↗ | A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee | Completed | Teva Branded Pharmaceutical Products R&D, Inc. | Phase 2 | The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee |
NCT02068599 ↗ | A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee | Completed | Teva Branded Pharmaceutical Products, R&D Inc. | Phase 2 | The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee |
NCT02365636 ↗ | A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN) | Completed | Teva Branded Pharmaceutical Products R&D, Inc. | Phase 2 | This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN |
NCT02365636 ↗ | A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN) | Completed | Teva Branded Pharmaceutical Products, R&D Inc. | Phase 2 | This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN |
NCT04826328 ↗ | Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy | Recruiting | Lotus Clinical Research, LLC | Phase 1 | This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa. |
NCT04826328 ↗ | Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy | Recruiting | Flexion Therapeutics, Inc. | Phase 1 | This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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