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

This study has been completed.
Sponsor:
Information provided by:
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT00414349
First received: December 20, 2006
Last updated: June 15, 2009
Last verified: June 2009
  Purpose

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)


Condition Intervention Phase
Neuropathic Pain
Drug: Topical analgesic
Drug: oral intake
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Topical analgesic
max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
Active Comparator: 2 Drug: oral intake
300 to 600 mg per day taken orally
Experimental: 3 Drug: Topical analgesic
3 plasters for PHN patients per day 4 plasters for DPN patients per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414349

Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Principal Investigator: Ralf Baron, Prof. Dr. Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany
  More Information

Publications:
Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT00414349     History of Changes
Other Study ID Numbers: 796838
Study First Received: December 20, 2006
Last Updated: June 15, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Grünenthal GmbH:
Topical analgesic
Multiple dose

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014