Trial design

AB Antoine Boden
AL Amélie Lusque
SL Sabrina Lodin
MB Marie Bourgouin
VM Valérie Mauries
CM Christelle Moreau
AF Amandine Fabre
MM Muriel Mounier
MP Muriel Poublanc
NC Nathalie Caunes-Hilary
TF Thomas Filleron
request Request a Protocol
ask Ask a question
Favorite

This is a Phase II, multicenter, randomized open-label and comparative study designed to evaluate whether Capsaïcin patches (Qutenza®) reduce neuropathic pain when compared to Amitriptyline (Laroxyl®) in head and neck cancer survivors presenting with neuropathic pain sequelae (ClinicalTrials.gov Identifier: NCT04704453). The primary endpoint is pain evaluated using a numeric scale. We opted for a randomized comparative phase II trial design rather than a single arm or a randomized non-comparative phase II trial to avoid obtaining false positive or false negative results only related to the study hypothesis [17]. All head and neck cancer patients presenting with neuropathic pain sequelae will be eligible for inclusion into the study. Patients that give their informed consent will be enrolled and randomized into the Amitriptyline (Laroxyl®) or Capsaïcin patch (Qutenza®) arm of the study.

Do you have any questions about this protocol?

Post your question to gather feedback from the community. We will also invite the authors of this article to respond.

post Post a Question
0 Q&A