Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

Pain Clinical Trial

Official title:

Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752322
• Other study ID #: KF10004/10
• Secondary ID: 2012-000347-28
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: July 5, 2016
• Start date: October 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Grünenthal GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Health and Medicines AuthoritySpain: Agencia Española de Medicamentos y Productos SanitariosAustria: Agency for Health and Food SafetyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: The Italian Medicines AgencyBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator's opinion, may preclude the subject's participation in the trial.

• History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to enrollment.

• Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.

• Pending litigation due to chronic pain or disability.

• Total anesthesia in the cutaneous area neurologically related to the location of the surgical intervention.

• Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anesthetics of the amide type.

• Any former use of topical lidocaine in the area of localized chronic PoNP.

• Severe renal, hepatic or heart disorder.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain
• Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine 5% medicated plaster

• Placebo plaster

Locations

Country	Name	City	State
Austria	AUT004	Klagenfurt
Austria	AUT005	Senftenberg
Austria	AUT002	Vienna
Austria	AUT003	Vienna
Austria	AUT006	Vienna
Austria	AUT001	Wien
Belgium	BEL001	Gozée
Belgium	BEL006	Halen
Belgium	BEL004	Ham
Belgium	BEL007	Lanaken
Belgium	BEL002	Natoye
Brazil	BRA005	Barretos
Brazil	BRA002	Itajai
Brazil	BRA001	Porto Alegre
Brazil	BR008	Salvador
Brazil	BRA003	Sao Paulo
Brazil	BRA006	São Paulo
Brazil	BRA007	São Paulo
Denmark	DNK005	Copenhagen
Denmark	DNK004	Glostrup
Denmark	DNK001	Odense
France	FRA004	Amiens
France	FRA002	Bordeaux
France	FRA001	Boulogne Billancourt
France	FRA003	Le Chesnay
France	FRA005	Lille
France	FRA010	Montauban
France	FRA006	Nantes
France	FRA009	Paris
France	FRA008	Saint-Priest en Jarez
France	FR007	Toulouse
Italy	ITA004	Firenze
Italy	ITA003	Napoli
Italy	ITA001	Rome
Spain	ESP001	Barcelona
Spain	ESP002	Barcelona
Spain	ESP005	Madrid
Spain	ESP006	Madrid
United Kingdom	GBR003	Cardiff
United Kingdom	GBR001	Glasgow
United Kingdom	GBR004	Liverpool
United Kingdom	GBR002	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Brazil,  Denmark,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Days 78-85	No
Secondary	Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.		up to 12 weeks	No
Secondary	Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.		up to 12 weeks	No
Secondary	Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.		up to 12 weeks	No
Secondary	Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.		up to 12 weeks	No
Secondary	Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.		Day 85	No
Secondary	Pain intensity from mechanical dynamic allodynia (brush) testing.		Day 85	No
Secondary	Anxiety and depression scores of HADS.		Day 85	No
Secondary	The weighted Health Status Index of quality of life by means of EQ 5D.		Day 85	No
Secondary	Total score in quality of sleep using CPSI.		Day 85	No
Secondary	Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.		up to 12 weeks	No
Secondary	Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.		up to 12 weeks	No
Secondary	Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.		up to 12 weeks	No
Secondary	Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.		up to 12 weeks	No
Secondary	Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.		Day 85	No
Secondary	Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.		Day 85	No
Secondary	Change from baseline in anxiety and depression scores of HADS.		Day 85	No
Secondary	Change from baseline in total score of quality of life by means of EQ 5D.		Day 85	No
Secondary	Change from baseline in total score in quality of sleep using CPSI.		Day 85	No