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Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP (DIDOCAP)

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ClinicalTrials.gov Identifier: NCT02869867
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Brief Summary:

Nursing study, prospective, randomized, two-center open-label.

Patients will be randomized into two groups during their first laying Qutenza®:

  • Patients receiving the laying of Qutenza® without refrigerated cushion
  • Patients receiving the laying of Qutenza® associated with a refrigerated cushion

The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.


Condition or disease Intervention/treatment Phase
Localized Neuropathic Pain Other: refrigerated cushion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ? - DIDOCAP
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
No Intervention: Qutenza® without refrigerated cushion
Qutenza® without refrigerated cushion
Experimental: Qutenza® with refrigerated cushion
Qutenza® with refrigerated cushion
Other: refrigerated cushion
refrigerated cushion




Primary Outcome Measures :
  1. visual analogue pain scale (burning pain) [ Time Frame: after 1 hour of installation of Qutenza patch ]
    visual analogue pain scale (burning pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major
  • Do not opposing the participation in the study
  • Monitoring in the case of localized neuropathic pain
  • Diagnostic with neuropathic pain score ≥ 4
  • Neuropathic pain conventional treatment failure of first-line
  • Front advantage of laying a first patch Qutenza®
  • With ability to understand the proposed study

Exclusion Criteria:

  • Patch Installation on the feet, face, mucous membranes
  • Eutectic mixture of local anesthetics (EMLA) Pose premedication
  • Having Already received prior to the installation of a patch of Qutenza®
  • Allergy to components Qutenza®
  • Known and poorly stabilized hypertension
  • Known cryoglobulinaemia
  • Pregnant or lactating women
  • Patient enjoying a measure of legal protection (guardianship, guardianship ...)
  • Private Patient freedom
  • No affiliation to a social security scheme.
  • Refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869867


Contacts
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Contact: Lucie AUZANNEAU 0251446380 ext 33 lucie.auzanneau@gmail.com

Locations
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France
CHLVO de Challans Not yet recruiting
Challans, France, 85300
Contact: Natacha TAILLIEZ, Nurse         
CHD Vendée de la Roche sur Yon Recruiting
La Roche sur Yon, France, 85925
Contact: Yves-Marie PLUCHON, PH         
Clinique Brétéché Not yet recruiting
Nantes, France, 44000
Contact: Audrey MILLET, Nurse         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02869867     History of Changes
Other Study ID Numbers: CHD049-16
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs