Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

Pain Clinical Trial

Official title:

Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01155986
• Other study ID #: 761541
• Secondary ID: 2009-016337-10
• Status: Terminated
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2019
• Source: Grünenthal GmbH
• Contact: n/a
• Is FDA regulated: No
• 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.

Description:

Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients.

This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects with >= 18 years of age

• Intact skin in the area of topical treatment

• Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.

• Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).

Exclusion Criteria:

• Contraindications to lidocaine 5% medicated plaster, or paracetamol

• Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.

• Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.

• Pregnant or breastfeeding women

• Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.

• Severe renal, hepatic or heart disorder.

• Surgery in the past 3 months before screening.

• Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.

• Pending litigation due to chronic pain or disability.

• 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.

• Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.

• For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).

• Total anesthesia in the area of localized chronic pain

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lidocaine 5% medicated plaster
Topical hydrogel plaster (700mg lidocaine)
• Placebo topical plaster
Topical hydrogel plaster

Locations

Country	Name	City	State
France	Site 31	Abbeville
France	Site 26	Bayonne
France	Site 34	Bobigny
France	Site 35	Bordeaux
France	Site 12	Boulogne-Billancourt
France	Site 24	Brest
France	Site 15	Chateauroux
France	Site 30	Corbeil Essonnes
France	Site 39	La Roche Sur Yon
France	Site 23	Lille cedex
France	Site 17	Limoges
France	Site 21	Marseille
France	Site 33	Montauban
France	Site 14	Nice Cedex 1
France	Site 18	Orleans
France	Site 27	Paris
France	Site 36	Paris
France	Site 22	Rennes Cedex
France	Site 19	Saint Genis Laval
France	Site 20	Saint-Etienne cedex 2
France	Site 38	Tours
France	Site 28	Voiron

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain	Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable).; Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).	daily assessments over 4 weeks
Secondary	Effect of lidocaine 5% medicated plaster on quality of life	EuroQol-5 Dimension Scores	4 weeks
Secondary	Neuropathic Pain Symptoms	Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations	4 weeks
Secondary	Incidence of adverse events	Measurement of adverse events including those derived from laboratory data or vital signs measurements.	up to 44 days
Secondary	Hospital Anxiety and Depression Scale		4 weeks
Secondary	Subject's Global Impression of Change		4 weeks
Secondary	Treatment Satisfaction Questionnaire for Medication		4 weeks