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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR PRILOCAINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for prilocaine hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Conselho Nacional de Desenvolvimento Científico e Tecnológico Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed University of Campinas, Brazil Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for prilocaine hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00154167 ↗ Safety and Efficacy Study of NV-101 in Dental Patients Completed Novalar Pharmaceuticals, Inc. Phase 2 2003-02-01 The purpose of this study was: - to determine if NV-101 accelerates recovery from numbness compared to placebo - to evaluate safety of NV-101
NCT00355277 ↗ Local Anaesthetic Effects of Transcutaneous Amitriptyline Completed University Hospital, Clermont-Ferrand Phase 1 2005-11-01 The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.
NCT00408941 ↗ EEG and Auditory Evoked Potentials During Local Anesthesia Unknown status Technische Universität München Phase 4 2006-12-01 The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.
NCT00444626 ↗ A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) Completed Mentor Worldwide, LLC Phase 3 2007-05-01 The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
NCT00444626 ↗ A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) Completed Genzyme, a Sanofi Company Phase 3 2007-05-01 The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel (hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery) as compared to injection with Restylane (a Food and Drug Administration (FDA) approved dermal filler) in patients undergoing cutaneous correction of the nasolabial folds (NLFs).
NCT00483990 ↗ Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers Completed Plethora Solutions Ltd Phase 1 2007-03-01 The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers
NCT00556478 ↗ Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Completed Shionogi Inc. Phase 2/Phase 3 2007-10-01 The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for prilocaine hydrochloride

Condition Name

Condition Name for prilocaine hydrochloride
Intervention Trials
Pain 13
Healthy 6
Premature Ejaculation 4
Contraception 4
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Condition MeSH

Condition MeSH for prilocaine hydrochloride
Intervention Trials
Pain, Postoperative 6
Acute Pain 4
Premature Ejaculation 4
Premature Birth 3
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Clinical Trial Locations for prilocaine hydrochloride

Trials by Country

Trials by Country for prilocaine hydrochloride
Location Trials
United States 44
Egypt 13
Belgium 10
Turkey 8
France 6
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Trials by US State

Trials by US State for prilocaine hydrochloride
Location Trials
North Carolina 4
New York 4
California 4
Utah 3
Florida 3
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Clinical Trial Progress for prilocaine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for prilocaine hydrochloride
Clinical Trial Phase Trials
Phase 4 38
Phase 3 14
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for prilocaine hydrochloride
Clinical Trial Phase Trials
Completed 61
Unknown status 14
Not yet recruiting 13
[disabled in preview] 19
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Clinical Trial Sponsors for prilocaine hydrochloride

Sponsor Name

Sponsor Name for prilocaine hydrochloride
Sponsor Trials
Cairo University 7
Plethora Solutions Ltd 5
Centre Hospitalier Universitaire Saint Pierre 5
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Sponsor Type

Sponsor Type for prilocaine hydrochloride
Sponsor Trials
Other 120
Industry 14
NIH 2
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