Neuropathic PainPhase 3NCT00414349
Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain
A Phase 3 study testing Topical analgesic and oral intake in people with Neuropathic Pain, run by Grünenthal GmbH at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Topical analgesic and oral intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2006to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.
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)
- Conditions
- Neuropathic Pain
- Being tested
- Topical analgesic, oral intake
- Keywords
- Topical analgesic, Multiple dose
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical analgesicDrug
max. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients
oral intakeDrug
300 to 600 mg per day taken orally
Topical analgesicDrug
3 plasters for PHN patients per day 4 plasters for DPN patients per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Topical analgesic |
| 2 | Active comparator | Not described Receives: Drug: oral intake |
| 3 | Experimental | Not described Receives: Drug: Topical analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Baron, Prof. Dr., Principal investigator, Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414349
- Sponsor's protocol ID
- 796838
- Other IDs
- KF10004/03
- Status last verified
- Oct 2019
- First submitted
- 20 Dec 2006
- Last updated
- 9 Oct 2019
- Results posted
- No
Publications
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.
PubMed 19485723Baron 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.
PubMed 19480610Baron 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.
PubMed 19301937
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lidocaine 5% Medicated Plaster in Comparison to Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain.
- ClinicalTrials.gov ID
- NCT00414349
- Acronym / sponsor ID
- 796838
- Conditions
- Neuropathic Pain
- Keywords
- Topical analgesic, Multiple dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Topical analgesic |
| 2 | Active comparator | Drug: oral intake |
| 3 | Experimental | Drug: Topical analgesic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical analgesicmax. 3 plasters per day for PHN patients max. 4 plasters per day for DPN patients | Drug | 1 |
| oral intake300 to 600 mg per day taken orally | Drug | 2 |
| Topical analgesic3 plasters for PHN patients per day 4 plasters for DPN patients per day | Drug | 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Results publication: PubMed 19485723Baron 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 publication: PubMed 19480610Baron 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 publication: PubMed 19301937Baron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Baron, Prof. Dr. principal investigator
Klinik für Neurologie, Christian-Albrechts-Universität Kiel, Schittenhelmstr. 10, 24105 Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical analgesic and oral intake in people with Neuropathic Pain, run by Grünenthal GmbH at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.