PainPhase 2NCT01155986
Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
A Phase 2 study testing Lidocaine 5% medicated plaster in people with Pain and Chronic Pain, run by Grünenthal GmbH at 22 sites in France.
Trial summary
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Neuropathic Pain
- What is being tested?
- Lidocaine 5% medicated plaster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 22 sitesFrance
- Study dates
- Aug 2010to Nov 2012
- Phase
- Phase 2
- 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
- Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
- Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).
Who cannot join
- Contraindications to lidocaine 5% medicated plaster, or paracetamol
- Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
- Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, 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.
- Severe renal, hepatic or heart disorder.
Show all 13Show fewer
- Surgery in the past 3 months before screening.
- Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
- Pending litigation due to chronic pain or disability.
- 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.
- Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.
- For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).
- Total anesthesia in the area of localized chronic pain
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Site 31
Abbeville
Site 26
Bayonne
Site 34
Bobigny
Site 35
Bordeaux
Site 12
Boulogne-Billancourt
Site 24
Brest
Site 15
Châteauroux
Site 30
Corbeil-Essonnes
Site 39
La Roche-sur-Yon
Site 23
Lille
Site 17
Limoges
Site 21
Marseille
Site 33
Montauban
Site 14
Nice
Site 18
Orléans
Site 27
Paris
Site 36
Paris
Site 22
Rennes
Site 20
Saint-Etienne
Site 19
Saint-Genis-Laval
Site 38
Tours
Site 28
Voiron
About this study
Official title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Read the detailed description
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients.
This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.
- Conditions
- Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain
- Being tested
- Lidocaine 5% medicated plaster, Placebo topical plaster
- Keywords
- analgesic, analgesics, pain, chronic pain, localized pain, focal pain, neuropathic pain, postoperative pain, topical analgesia
- Medical subject headings
- Pain, Chronic Pain, Neuralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 5% medicated plasterDrug
Also called Versatis(R)
Topical hydrogel plaster (700mg lidocaine)
Placebo topical plasterDrug
Topical hydrogel plaster
| Study group | Role | What they receive |
|---|---|---|
| Placebo Plaster | Placebo comparator | Active Comparator Receives: Drug: Placebo topical plaster |
| Lidocaine Plaster | Active comparator | Not described Receives: Drug: Lidocaine 5% medicated plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable).
Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
Measured: daily assessments over 4 weeks
Secondary outcomes (6)
Effect of lidocaine 5% medicated plaster on quality of life
EuroQol-5 Dimension Scores
Measured: 4 weeks
Neuropathic Pain Symptoms
Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
Measured: 4 weeks
Incidence of adverse events
Measurement of adverse events including those derived from laboratory data or vital signs measurements.
Measured: up to 44 days
Hospital Anxiety and Depression Scale
Measured: 4 weeks
Subject's Global Impression of Change
Measured: 4 weeks
Treatment Satisfaction Questionnaire for Medication
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 posted2 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Trial was stopped due to difficult enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Bruxelle, Principal investigator, Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155986
- Sponsor's protocol ID
- 761541
- Other IDs
- 2009-016337-10, 2009
- Status last verified
- Oct 2019
- First submitted
- 1 Jul 2010
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.
- ClinicalTrials.gov ID
- NCT01155986
- Acronym / sponsor ID
- 761541
- Conditions
- Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain
- Keywords
- analgesic, analgesics, pain, chronic pain, localized pain, focal pain, neuropathic pain, postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was stopped due to difficult enrolment
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Jul 2010 (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 trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Detailed description
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients.
This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Plaster | Placebo comparator | Drug: Placebo topical plasterActive Comparator |
| Lidocaine Plaster | Active comparator | Drug: Lidocaine 5% medicated plaster |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects with >= 18 years of age
- Intact skin in the area of topical treatment
- Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
- Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).
Key exclusion criteria (13 listed)
- Contraindications to lidocaine 5% medicated plaster, or paracetamol
- Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
- Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, 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 |
|---|---|---|
| Lidocaine 5% medicated plasterAlso: Versatis(R)Topical hydrogel plaster (700mg lidocaine) | Drug | Lidocaine Plaster |
| Placebo topical plasterTopical hydrogel plaster | Drug | Placebo Plaster |
Primary outcome
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain
Time frame: daily assessments over 4 weeks
Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS).
6 secondary outcomes
Effect of lidocaine 5% medicated plaster on quality of life
Time frame: 4 weeks
Neuropathic Pain Symptoms
Time frame: 4 weeks
Incidence of adverse events
Time frame: up to 44 days
Hospital Anxiety and Depression Scale
Time frame: 4 weeks
Subject's Global Impression of Change
Time frame: 4 weeks
Treatment Satisfaction Questionnaire for Medication
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Trial was stopped due to difficult enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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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.
Jean Bruxelle principal investigator
Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine 5% medicated plaster in people with Pain and Chronic Pain, run by Grünenthal GmbH at 22 sites in France.
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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 16 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 22 sites in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Trial was stopped due to difficult enrolment). Results are not available in the source record.
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?
Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain (time frame: daily assessments over 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2019.