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Trial record 1 of 1 for:    NCT00414349
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Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain

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ClinicalTrials.gov Identifier: NCT00414349
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE December 20, 2006
First Posted Date  ICMJE December 21, 2006
Last Update Posted Date October 9, 2019
Study Start Date  ICMJE December 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
Reduction of pain expressed by response rate after 4 weeks treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
  • every 4 weeks of single or combination treatment:
  • change in neuropathic pain
  • change in quality of life
  • change in sleep quality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain
Official Title  ICMJE Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE
  • Drug: Topical analgesic
    max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
  • Drug: oral intake
    300 to 600 mg per day taken orally
  • Drug: Topical analgesic
    3 plasters for PHN patients per day 4 plasters for DPN patients per day
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Topical analgesic
  • Active Comparator: 2
    Intervention: Drug: oral intake
  • Experimental: 3
    Intervention: Drug: Topical analgesic
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2019)
431
Original Enrollment  ICMJE
 (submitted: December 20, 2006)
350
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00414349
Other Study ID Numbers  ICMJE 796838
KF10004/03 ( Other Identifier: Sponsor study number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ralf Baron, Prof. Dr. Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany
PRS Account Grünenthal GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP