Safety and efficacy of lidocaine 5% medicated plaster in comparison with pregabalin in postherpetic neuralgia and diabetic polyneuropathic pain

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2006-003132-29-ES
• Date of registration: 15/03/2012
• Prospective Registration: No
• Primary sponsor: Laboratorios Andrómaco, S.A.
• Public title: Safety and efficacy of lidocaine 5% medicated plaster in comparison with pregabalin in postherpetic neuralgia and diabetic polyneuropathic pain
• Scientific title: Eficacia y Seguridad de un parche de lidocaína al 5% comparado con pregabalina en neuralgia post-herpética y dolor por polineuropatía diabética. - n.a.
• Date of first enrolment: 01/12/2006
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003132-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: adaptado en dos etapas, estratificado por indicación If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Croatia, Czech Republic, Germany, Ireland, Italy, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, United Kingdom

Contacts

• Name: Gerente de registros
• Affiliation: Laboratorios Andrómaco, S.A.

• Name: Gerente de registros
• Affiliation: Laboratorios Andrómaco, S.A.

Key inclusion & exclusion 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.
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 < 1 (e.g. most oral contraceptives, intra-uterine device (IUD) method with hormonal supplement, or male or female condom with diaphragm and a spermicidal agent [foam, jelly, or cream]) for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit. Women of childbearing age must be counseled about the use of adequate contraception.
? Subjects with severe cardiac impairment e.g. NYHA class > 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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Neuralgia post herpética y dolor por polineuropatía diabética.
MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Body processes [G] - Biological Phenomena [G16]

Intervention(s)

Product Name: Parche de lidocaína al 5%
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Lidocaina
CAS Number: 137-58-6
Other descriptive name: 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 700-

Trade Name: Lyrica® 75 mg cápsulas duras
Product Name: Lyrica® 75 mg cápsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: pregabalina
CAS Number: 148553.50-8
Current Sponsor code: n.a.
Other descriptive name: (S)-3-(aminomethyl)-5-methylhexanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Secondary Objective: ? Estimate the suitability of lidocaine 5% medicated plaster as stand-alone medication, as an alternative to and in combination with pregabalin.
? Evaluate the safety and efficacy of lidocaine 5% medicated plaster in combination with pregabalin.
? Evaluate the pregabalin-sparing effect of lidocaine 5% medicated plaster by down-titrating pregabalin (sub-study).

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

Timepoint(s) of evaluation of this end point: After 4 weeks of treatment

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 Outcome(s)

Secondary end point(s): ? Clinical Global Impression of Change (CGIC) at Visits 4, 6, 7, and 8, and the Switch Visit.
? Patient Global Impression of Change (PIGC) at Visits 4, 6, 7, and 8, and the Switch Visit.
? Subject satisfaction with the treatment at Visits 1, 4, 6, 7, and 8 and the Switch Visit.
? Recalled average pain intensity over the last 3 days at each visit (NRS-3) and changes from Baseline.
? Percentage of subjects with 30% and 50% reduction in pain score based on the NRS-3 compared to Baseline at Visit 4 and Visit 7.
? Daily pain assessment from Visit 2 to Visit 4: average pain intensity during the last 24 hours (recorded in the evening; A NRS) and worst pain intensity during the last 24 hours (recorded in the evening; W-NRS) and changes from Baseline
? Time to onset of response: Time between Baseline and the first day of a 3-day period with an A-NRS decreased by at least 2 points or an A-NRS ? 4 on all 3 days.
? Time to onset of pain relief on Day 0 (only for subjects treated with lidocaine 5% medicated plaster).
? Neuropathic Pain Symptom Inventory (NPSI) at Visits 1, 2, 4, 6, 7, 8, and the Switch Visit, and changes from Baseline.
? SF-MPQ (Short Form McGill Pain Questionnaire) at Visits 1, 2, 4, 6, 7, 8, and the Switch Visit, and changes from Baseline.
? SF-36 at Visits 1, 2, 4, 6, 7, 8, and the Switch Visit, and changes from Baseline.
? EuroQol-5 Dimension (EQ-5D; quality of life index) at Visits 1, 2, 4, 6, 7, 8, and the Switch Visit, and changes from Baseline.
? Chronic Pain Sleep Inventory (CPSI) at Visits 1, 2, 4, 6, 7, 8, and the Switch Visit, and changes from Baseline.
? Allodynia severity rating at Visits 1, 2, 4, 6, 7, 8 and the Switch Visit, and changes from Baseline.
? Number of plasters used to cover the most painful areas
? Use of rescue medication
Secondary safety endpoint criteria:
? Safety laboratory.
? Vital signs.
? Physical examination.
? Adverse events.
? Concomitant medication.
? Time to withdrawal due to adverse event and adverse drug reaction (ADR).
Sub-study endpoint criterion:
? Pregabalin-sparing effect of lidocaine 5% medicated plaster (decrease of pregabalin dose while maintaining an NRS-3 ?4). For each subject, whose pregabalin-dose can be reduced during the down-titration phase without resulting in an NRS-3>4, a pregabalin-sparing effect is achieved

Timepoint(s) of evaluation of this end point: 16 weeks

Secondary ID(s)

2006-003132-29-IE

KF10004/03

Source(s) of Monetary Support

Laboratorios Andrómaco, S.A.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 19/07/2015
• Date Completed: 04/04/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003132-29/results