Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain

• ClinicalTrials.gov Identifier: NCT00414349
• Recruitment Status: Completed
• First Posted: December 21, 2006
• Last Update Posted: October 9, 2019
• Sponsor: Grünenthal GmbH
• Information provided by (Responsible Party): Grünenthal GmbH

Study Description

Brief Summary:

The purpose of this study is to evaluate lidocaine as topical treatment for peripheral neuropathic pain (as stand-alone treatment and in combination with systemic treatment)

Condition or disease	Intervention/treatment	Phase
Neuropathic Pain	Drug: Topical analgesic; Drug: oral intake	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 431 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.
• Study Start Date: December 2006
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: Topical analgesic; max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
Active Comparator: 2	Drug: oral intake; 300 to 600 mg per day taken orally
Experimental: 3	Drug: Topical analgesic; 3 plasters for PHN patients per day 4 plasters for DPN patients per day

Outcome Measures

Primary Outcome Measures :

1. Reduction of pain expressed by response rate after 4 weeks treatment every 4 weeks of single or combination treatment: change in neuropathic pain, change in quality of life, change in sleep quality [ Time Frame: 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female subjects with >= 18 years of age
• Intact skin in the area of topical treatment
• Creatinine clearance CLCR >= 30 mL/min
• NRS-3 > 4 (recalled average pain intensity during the last 3 days)

Subjects with DPN

• Controlled, treated type 1 or 2 diabetes mellitus with glycosylated hemoglobin (Hba1c)<= 11%
• Painful, distal symmetrical, sensomotor polyneuropathy of the lower extremities for >= 3 months (below the knees on both extremities) with at least 2 of the following symptoms present: burning, sensation, tingling or prickling, numbness from time to time, painful heat or cold sensation (e.g. warm or cold water)

Subjects with PHN

• Subjects with PHN and neuropathic pain present for >= 3 months after healing of the herpes zoster skin rash.
• Without neurolytic neurosurgical therapy for their condition.

Exclusion Criteria:

General

• Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 2 years, unstable psychological personality requiring intermittent or permanent treatment.
• Psychiatric illness (subjects with well-controlled depression or anxiety disorder may participate if they are not taking any of the prohibited medications defined (below), epilepsy 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.
• Subjects with severe cardiac impairment e.g. NYHA class > 3, myocardial infarction less than 6 months prior to enrollment, and/or unstable angina pectoris.
• Subjects with severe hepatic disorder and/or AST or ALT >= 3x the upper limit of normal.
• Subjects with known or suspected severe renal failure (CLCR < 30 mL/min).
• Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
• Subjects who are undergoing active treatment for cancer, are known to be infected with HIV or being acutely and intensively immunosuppressed following transplantation.
• 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.

Trial specific:

• Any concomitant use of drugs for the treatment of neuropathic pain or commonly used for the treatment of neuropathic pain.
• Use of transcutaneous electrical nerve stimulations (TENS) after enrollment.
• CLCR < 30 mL/min
• Evidence of another cause for pain in the area of neuropathic pain such as lumbar radiculopathy, surgery trauma, restless legs syndrome, if this coud confound the assessment or self-evaluation of the neuropathic pain.
• Presence of other severe pain that could confound the assessment or self-evaluation of the neuropathic pain.
• History of malignancy within the past 5 years (with the exception of basal cell carcinoma).

Subjects with PHN

• Active herpes zoster lesion or dermatitis of any origin at the affected site with PHN.
• Subjects who had neurological ablation by block or neurosurgical intervention for control of pain in PHN.

Subjects with DPN

• No palpable pulse of the arteria dorsalis pedis in both feet.
• Clinical signs for venous insufficiency and/or postthrombotic syndrome Sage III/IV (i.e. extensive varicoses)
• Ulcers on the lower extremities.

Contacts and Locations

Locations

United Kingdom

London, United Kingdom

Sponsors and Collaborators

Grünenthal GmbH

Investigators

• Principal Investigator: Ralf Baron, Prof. Dr.; Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany

More Information

Publications of Results:

Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I, Serpell M. 5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study. Curr Med Res Opin. 2009 Jul;25(7):1663-76. doi: 10.1185/03007990903047880.

Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I, Serpell M. Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin. 2009 Jul;25(7):1677-87. doi: 10.1185/03007990903048078.

Baron R, Mayoral V, Leijon G, Binder A, Steigerwald I, Serpell M. Efficacy and safety of 5% lidocaine (lignocaine) medicated plaster in comparison with pregabalin in patients with postherpetic neuralgia and diabetic polyneuropathy: interim analysis from an open-label, two-stage adaptive, randomized, controlled trial. Clin Drug Investig. 2009;29(4):231-41. doi: 10.2165/00044011-200929040-00002.

• Responsible Party: Grünenthal GmbH
• ClinicalTrials.gov Identifier: NCT00414349
• Other Study ID Numbers: 796838; KF10004/03 ( Other Identifier: Sponsor study number )
• First Posted: December 21, 2006
• Last Update Posted: October 9, 2019
• Last Verified: October 2019

Keywords provided by Grünenthal GmbH:

Topical analgesic; Multiple dose

Additional relevant MeSH terms:

Neuralgia; Neuralgia, Postherpetic; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs