Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain
Phase 3
Completed
- Conditions
- Neuropathic Pain
- Interventions
- Drug: Topical analgesicDrug: oral intake
- Registration Number
- NCT00414349
- Lead Sponsor
- Grünenthal GmbH
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 431
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Topical analgesic - 2 oral intake - 3 Topical analgesic -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method