Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain (NCT01752322) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
Austria444 participantsStarted 2012-10
Plain-language summary
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects aged 18 years or older.
* Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
* Localized PoNP present for at least 3 months.
* Size of the affected painful skin area is not larger than the size of 3 plasters.
* Intact skin besides the scar of surgery in the area of plasters application
* Baseline average pain intensity of 4 or greater on the 11 point pain intensity Numeric Rating Scale.
Exclusion Criteria:
* Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial.
* Previous enrollment in this trial.
* History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment.
* Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation.
* Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
* Any surgery performed in the 3 months prior to enrollment, which may affect efficacy or safety assessment.
* Any surgery scheduled or expected during the trial.
*…
What they're measuring
1
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.