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Clinical Trials/EUCTR2011-002083-25-DE
EUCTR2011-002083-25-DE
Active, not recruiting
Not Applicable

Is there a correlation between the pain relief and the A-delta- and C-fiber function after topical application of lidocaine (5%) in patients with peripheral neuropathic pain?

BG University Hospital Bergmannsheil GmbH0 sites30 target enrollmentJuly 25, 2011
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
BG University Hospital Bergmannsheil GmbH
Enrollment
30
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 25, 2011
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
BG University Hospital Bergmannsheil GmbH

Eligibility Criteria

Inclusion Criteria

  • •Included will be patients 18 years and older either genera with:
  • •\-Proven Diagnosis of painful peripheral neuropathy for at least 3 months as diagnosed as:
  • •1\.Peripheral nerve lesion (i.e. pain within or adjacent to the area of nerve trauma or corresponding innervation territory or dermatome)
  • •2\.Postherpetic neuralgia (Subjects with pain following herpes zoster with \> 3 months after healing of herpes zoster skin rash).
  • •\- At least moderate pain intensity under the current treatment.
  • •\- Unchanged and stable pain medication within the last 4 weeks.
  • •\- The patients have to display some remaining sensory function at the baseline QST.
  • •\- Intact skin in the area of lidocaine medicated plaster application.
  • •\- Females with childbearing potential must be using adequate contraception.
  • •\- Women of childbearing potential must have a negative urine ß\-human chorionic gonadotropin (ß\-HCG) pregnancy test.

Exclusion Criteria

  • •Excluded will be patients with:
  • •\- History of current alcohol or drug abuse.
  • •\- Any scheduled surgery of painful procedure during the course of the trial.
  • •\- Presence of a disease that affects the subject’s compliance.
  • •\- Use of any topical anaesthetics in the area of pain within the last 6 months.
  • •\- Use of capsaicin (low or high\-dose) in the area of pain within the last 6 months.
  • •\- Use of TENS within the area of pain in the last 4 weeks.
  • •\- Subjects who had nerve ablation by block or neurosurgical intervention for pain treatment at the affected area.
  • •\- Evidence or another cause of pain within the area of pain or another severe pain condition that may interfere with the trial aims or procedures.
  • •\- Severe loss of sensory function

Outcomes

Primary Outcomes

Not specified

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