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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Topical analgesic
oral intake
Topical analgesic
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Topical analgesic, Multiple dose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2006
Last Updated
October 7, 2019
Sponsor
Grünenthal GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00414349
Brief Title
Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain
Official Title
Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Topical analgesic, Multiple dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topical analgesic
Intervention Description
max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
Intervention Type
Drug
Intervention Name(s)
oral intake
Intervention Description
300 to 600 mg per day taken orally
Intervention Type
Drug
Intervention Name(s)
Topical analgesic
Intervention Description
3 plasters for PHN patients per day 4 plasters for DPN patients per day
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Baron, Prof. Dr.
Organizational Affiliation
Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany
Official's Role
Principal Investigator
Facility Information:
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19485723
Citation
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.
Results Reference
result
PubMed Identifier
19480610
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):1677-87. doi: 10.1185/03007990903048078.
Results Reference
result
PubMed Identifier
19301937
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 an open-label, two-stage adaptive, randomized, controlled trial. Clin Drug Investig. 2009;29(4):231-41. doi: 10.2165/00044011-200929040-00002.
Results Reference
result

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

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