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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Grünenthal GmbH
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01752322
First received: September 12, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pain
Chronic Pain
Neuropathic Pain
Postoperative Pain
Drug: Lidocaine 5% medicated plaster
Drug: Placebo plaster
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • 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. [ Time Frame: Days 78-85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Anxiety and depression scores of HADS. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Total score of quality of life by means of EQ 5D. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Total score in quality of sleep using CPSI. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change from baseline in anxiety and depression scores of HADS. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change from baseline in total score of quality of life by means of EQ 5D. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
  • Change from baseline in total score in quality of sleep using CPSI. [ Time Frame: Day 85 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine plaster
Topical hydrogel plaster
Drug: Lidocaine 5% medicated plaster
Placebo Comparator: Placebo plaster
Topical hydrogel plaster
Drug: Placebo plaster

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  • 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 site of surgery.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752322

Contacts
Contact: Grünenthal Clinical Trial Helpdesk + 49 241 569 3223 clinical-trials@grunenthal.com
Contact: René Allard + 49 241 569 3223 clinical-trials@grunenthal.com

  Show 38 Study Locations
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Study Director: Study Director Grünenthal GmbH
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01752322     History of Changes
Other Study ID Numbers: KF10004/10, 2012‐000347‐28
Study First Received: September 12, 2012
Last Updated: July 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Health and Medicines Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Austria: Agency for Health and Food Safety
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Neuralgia
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014