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

NCT ID: NCT00414349

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Topical analgesic

Intervention Type: DRUG

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

2

Group Type: ACTIVE_COMPARATOR

oral intake

Intervention Type: DRUG

300 to 600 mg per day taken orally

3

Group Type: EXPERIMENTAL

Topical analgesic

Intervention Type: DRUG

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

Interventions

Topical analgesic

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

Intervention Type: DRUG

oral intake

300 to 600 mg per day taken orally

Intervention Type: DRUG

Topical analgesic

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Baron, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 19485723 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19480610 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19301937 (View on PubMed)

Other Identifiers

KF10004/03

Identifier Type: OTHER

Identifier Source: secondary_id

796838

Identifier Type: -

Identifier Source: org_study_id