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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752322
First Posted: December 19, 2012
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Grünenthal GmbH
  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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

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 ]

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 ]
  • 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 ]
  • Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours. [ Time Frame: up to 12 weeks ]
  • Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ]
  • Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ]
  • Pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ]
  • Anxiety and depression scores of HADS. [ Time Frame: Day 85 ]
  • The weighted Health Status Index of quality of life by means of EQ 5D. [ Time Frame: Day 85 ]
  • Total score in quality of sleep using CPSI. [ Time Frame: Day 85 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal. [ Time Frame: up to 12 weeks ]
  • Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [ Time Frame: Day 85 ]
  • Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing. [ Time Frame: Day 85 ]
  • Change from baseline in anxiety and depression scores of HADS. [ Time Frame: Day 85 ]
  • Change from baseline in total score of quality of life by means of EQ 5D. [ Time Frame: Day 85 ]
  • Change from baseline in total score in quality of sleep using CPSI. [ Time Frame: Day 85 ]

Enrollment: 444
Study Start Date: October 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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/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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752322


  Show 42 Study Locations
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Study Director: Study Director Grünenthal GmbH
  More Information

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01752322     History of Changes
Other Study ID Numbers: KF10004/10
2012‐000347‐28 ( EudraCT Number )
First Submitted: September 12, 2012
First Posted: December 19, 2012
Last Update Posted: July 6, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action