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

NCT00414349 | Completed Phase 3

• 2 other identifiers: 796838KF10004/03
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

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)

Conditions

Neuropathic Pain

Keywords

Topical analgesic; Multiple dose

Outcome Measures

Primary Outcomes (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

  4 weeks

Study Arms (3)

1

EXPERIMENTAL

Drug: Topical analgesic

2

ACTIVE COMPARATOR

Drug: oral intake

3

EXPERIMENTAL

Drug: Topical analgesic

Interventions

Topical analgesic DRUG

max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients

1

oral intake DRUG

300 to 600 mg per day taken orally

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 19485723 RESULT

• 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.

  PMID: 19480610 RESULT

• 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.

  PMID: 19301937 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ralf Baron, Prof. Dr.

  Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: December 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

GB (1)