postherpetic neuralgia and painful diabetic polyneuropathy MedDRA version: 8.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Interventions
Product Name: Lidocaine 5% medicated plaster
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Lidocaine
CAS Number: 137-58-6
Other descriptive name: 2-(diethylamino)-N-(2,6-dimethylphenyl)
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects with = 18 years of age. • Written informed consent given. • For women of childbearing potential, a negative urine pregnancy test. • Negative urine test for drugs of abuse with the exception of short and medium acting benzodiazepine users for insomnia. • Intact skin in the area of topical treatment. • NRS-3 > 4 (recalled average pain intensity during the last 3 days) • Creatinine clearance (CLCR) > 30mL/min Subjects with painful DPN • Controlled, treated type 1 or 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) = 11%. • Painful, distal, symmetrical, sensomotor polyneuropathy of the lower extremities for = 3 months (below the knees on both extremities) with at least 2 of the following symptoms present: burning sensation, tingling or prickling, paresthesias, painful heat or cold sensation (e.g. warm or cold water). • The most painful area is coverable by up to 4 plasters. Subjects with PHN • Subjects with PHN and neuropathic pain present for = 3 months after healing of the herpes zoster skin rash. • Without neurolytic neurosurgical therapy for their condition. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General • Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 2 years, unstable psychological personality requiring intermittent or permanent treatment. • Psychiatric illness (subjects with well-controlled depression or anxiety disorder may participate if they are not taking any of the prohibited medications defined below), epilepsy or suicide risk. • Pregnant or breastfeeding women. • Women of childbearing potential who are sexually active without satisfactory contraception, i.e. with a Pearl Index 3, myocardial infarction less than 6 months prior to enrollment, and/or unstable angina pectoris. • Subjects with severe hepatic disorder and/or AST or ALT = 3x the upper limit of normal. • Subjects with known or suspected severe renal failure (CLCR < 30 mL/min). • Anticipated need for surgery during the trial, requiring at least regional or general anesthesia. • Subjects who are undergoing active treatment for cancer, are known to be infected with HIV, or being acutely and intensively immunosuppressed following transplantation. • Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial. • Known to or suspected of not being able to comply with the trial protocol. • Not able to communicate meaningfully with the Investigator and staff. • Any dependency of the subject to the Investigator or the trial site, e.g. employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial site, as well as family members of the employees or the Investigator. • The investigator may exclude any potential subject for any safety concern or any other reason that according to the investigator’s assessment makes the patient not suitable for this trial. Trial-specific • Any former treatment with topical lidocaine for treatment of neuropathic pain, pregabalin, or gabapentin (during the last 6 months). • Any concomitant use of drugs for the treatment of neuropathic pain or commonly used for the treatment of neuropathic pain e.g.: • Non-SSRI antidepressant drugs (i.e. tricylcic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g. venlafaxine, duloxetine). • Non-steroidal anti-inflammatory drugs (NSAIDs, including COX-2 inhibitors) if not specifically allowed per protocol. • Monoamine oxidase inhibitors (MAO-inhibitors), • antieleptic drugs (e.g. carbamazepine, clonzepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin) besides the IMPs. • Benzodiazepines (except for short or medium acting benzodiazepines for insomnia). • Skeletal muscle relaxants. • Opioids (including dextromethorphan and tramadol), memantine, retinotoxins (e.g. hydroxychloroquine, deferoxamine, thioridazine, vigabatrin). • Known contraindications or hypersensitivity to local anesthetics of the amide type, pregabalin or paracetamol or to any of the excipients. • Administration of Class I anti-arrhythmic drugs (e.g. tocai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the safety and efficacy of lidocaine 5% medicated plaster versus pregabalin after 4 weeks of treatment in subjects with postherpetic neuralgia and diabetic polyneuropathic pain.;Secondary Objective: • To estimate the suitability of lidocaine 5% medicated plaster as stand-alone medication, as an alternative to and in combination with pregabalin. • To evaluate the safety and efficacy of lidocaine 5% medicated plaster in combination with pregabalin. • To evaluate the pregabalin-sparing effect of lidocaine 5% medicated plaster by down-titrating pregabalin. ;Primary end point(s): Decrease of NRS-3 (recalled average pain intensity during the last 3 days) after 4 weeks of treatment with lidocaine 5% medicated plaster or pregabalin as stand alone medication, i.e. between Week 4 (Visit 4) and Baseline (Visit 2), expressed as a response rate. Response is defined as a reduction of at least 2 points or a value of 4 or less on the NRS-3 scale after 4 weeks of treatment. All drop-outs will be defined as non-responders | — |
Countries
Austria, Czech Republic, Germany, Ireland, Italy, Portugal, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed