Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy | NCT01699854 | Trialant
TerminatedInterventionalPhase 3Updated Feb 26, 2014
Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy
ClinicalTrials.gov ID
NCT01699854
Lead Sponsor
Rigshospitalet, DenmarkOTHER
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 3
Enrollment
50Estimated
Last Update Posted
Feb 26, 2014Estimated
Start Date
Aug 2012
Primary Completion Date
Sep 2013Actual
Completion Date
Sep 2013Actual
Brief Summary
In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.
Persistent Pain After Inguinal Herniotomy
capsaicin patch (qutenza)
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale [NRS] 0-10 points) during rest or during movement > 5.
Exclusion Criteria:
History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III