Clinical trial NCT01752322: Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
Official title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Chronic Pain
Neuropathic Pain
Postoperative Pain
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Days 78-85
Secondary outcomes:
measure: 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.
timeFrame: up to 12 weeks
measure: 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.
timeFrame: up to 12 weeks
measure: Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
timeFrame: up to 12 weeks
measure: Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
timeFrame: up to 12 weeks
measure: Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
timeFrame: Day 85
measure: Pain intensity from mechanical dynamic allodynia (brush) testing.
timeFrame: Day 85
measure: Anxiety and depression scores of HADS.
timeFrame: Day 85
measure: The weighted Health Status Index of quality of life by means of EQ 5D.
timeFrame: Day 85
measure: Total score in quality of sleep using CPSI.
timeFrame: Day 85
measure: 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.
timeFrame: up to 12 weeks
measure: 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.
timeFrame: up to 12 weeks
measure: Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
timeFrame: up to 12 weeks
measure: Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
timeFrame: up to 12 weeks
measure: Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
timeFrame: Day 85
measure: Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
timeFrame: Day 85
measure: Change from baseline in anxiety and depression scores of HADS.
timeFrame: Day 85
measure: Change from baseline in total score of quality of life by means of EQ 5D.
timeFrame: Day 85
measure: Change from baseline in total score in quality of sleep using CPSI.
timeFrame: Day 85
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: AUT004
city: Senftenberg
country: Austria
facility: AUT005
city: Vienna
country: Austria
facility: AUT006
city: Vienna
country: Austria
facility: AUT002
city: Vienna
country: Austria
facility: AUT003
city: Wien
country: Austria
facility: AUT001
city: Gozée
country: Belgium
facility: BEL001
city: Halen
country: Belgium
facility: BEL006
city: Ham
country: Belgium
facility: BEL004
city: Lanaken
country: Belgium
facility: BEL007
city: Natoye
country: Belgium
facility: BEL002
city: Barretos
country: Brazil
facility: BRA005
city: Itajai
country: Brazil
facility: BRA002
city: Porto Alegre
country: Brazil
facility: BRA001
city: Salvador
country: Brazil
facility: BR008
city: Sao Paulo
country: Brazil
facility: BRA003
city: São Paulo
country: Brazil
facility: BRA006
city: São Paulo
country: Brazil
facility: BRA007
city: Copenhagen
country: Denmark
facility: DNK005
city: Glostrup
country: Denmark
facility: DNK004
city: Odense
country: Denmark
facility: DNK001
city: Amiens
country: France
facility: FRA004
city: Bordeaux
country: France
facility: FRA002
city: Boulogne Billancourt
country: France
facility: FRA001
city: Le Chesnay
country: France
facility: FRA003
city: Lille
country: France
facility: FRA005
city: Montauban
country: France
facility: FRA010
city: Nantes
country: France
facility: FRA006
city: Paris
country: France
facility: FRA009
city: Saint-Priest en Jarez
country: France
facility: FRA008
city: Toulouse
country: France
facility: FR007
city: Firenze
country: Italy
facility: ITA004
city: Napoli
country: Italy
facility: ITA003
city: Rome
country: Italy
facility: ITA001
city: Barcelona
country: Spain
facility: ESP001
city: Barcelona
country: Spain
facility: ESP002
city: Madrid
country: Spain
facility: ESP006
city: Madrid
country: Spain
facility: ESP005
city: Cardiff
country: United Kingdom
facility: GBR003
city: Glasgow
country: United Kingdom
facility: GBR001
city: Liverpool
country: United Kingdom
facility: GBR004
city: Manchester
country: United Kingdom
facility: GBR002
Study officials:
affiliation: Grünenthal GmbH
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.