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

Neuropathic Pain Clinical Trial

Official title:

Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414349
• Other study ID #: 796838
• Secondary ID: KF10004/03
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2019
• Source: Grünenthal GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain

Intervention

Drug:
• Topical analgesic
max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
• oral intake
300 to 600 mg per day taken orally
• Topical analgesic
3 plasters for PHN patients per day 4 plasters for DPN patients per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grünenthal GmbH

Country where clinical trial is conducted

United Kingdom, 

References & 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 — View Citation

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 a — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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