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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR QUTENZA


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All Clinical Trials for Qutenza

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01252160 ↗ Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage Completed Astellas Pharma Inc Phase 4 2010-10-28 In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.
NCT01260454 ↗ The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain Completed United Therapeutics Phase 2 2010-11-01 Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.
NCT01260454 ↗ The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain Completed University of Rochester Phase 2 2010-11-01 Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.
NCT01393795 ↗ Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients Completed United Therapeutics Phase 2 2011-08-01 The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza pre-application), in which case it would greatly improve the quality of life of the patients, and enable many more to continue with this treatment. It may also provide new information to support the use of Qutenza® patches for preventing and reducing pain produced by inflammation. The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary arterial hypertension patients, as assessed by changes in subjective pain rating score and/or pain and sensory testing.
NCT01393795 ↗ Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients Completed Imperial College London Phase 2 2011-08-01 The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza pre-application), in which case it would greatly improve the quality of life of the patients, and enable many more to continue with this treatment. It may also provide new information to support the use of Qutenza® patches for preventing and reducing pain produced by inflammation. The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary arterial hypertension patients, as assessed by changes in subjective pain rating score and/or pain and sensory testing.
NCT01416116 ↗ Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch Completed Astellas Pharma Inc Phase 4 2011-07-06 The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
NCT01478607 ↗ A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients Completed Astellas Pharma Inc Phase 3 2011-11-01 The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Qutenza

Condition Name

Condition Name for Qutenza
Intervention Trials
Neuropathic Pain 6
Pain 5
Pulmonary Hypertension 2
or Peripheral Nerve Injury (PNI) 1
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Condition MeSH

Condition MeSH for Qutenza
Intervention Trials
Neuralgia 14
Peripheral Nervous System Diseases 3
Neuralgia, Postherpetic 3
Hypertension, Pulmonary 2
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Clinical Trial Locations for Qutenza

Trials by Country

Trials by Country for Qutenza
Location Trials
United States 16
United Kingdom 10
Italy 10
France 8
Spain 6
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Trials by US State

Trials by US State for Qutenza
Location Trials
Texas 2
Michigan 2
Florida 2
New York 2
Ohio 1
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Clinical Trial Progress for Qutenza

Clinical Trial Phase

Clinical Trial Phase for Qutenza
Clinical Trial Phase Trials
Phase 4 5
Phase 3 7
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Qutenza
Clinical Trial Phase Trials
Completed 14
Unknown status 3
Recruiting 2
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Clinical Trial Sponsors for Qutenza

Sponsor Name

Sponsor Name for Qutenza
Sponsor Trials
Astellas Pharma Inc 4
Astellas Pharma Europe Ltd. 2
NHS Greater Glasgow and Clyde 2
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Sponsor Type

Sponsor Type for Qutenza
Sponsor Trials
Other 17
Industry 13
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