PainPhase 3NCT01752322
Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain
A Phase 3 study testing Lidocaine 5% medicated plaster in people with Pain and Chronic Pain, run by Grünenthal GmbH at 42 sites in 8 countries.
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
- 444 participants
- Where
- 42 sitesin 8 countries
- Study dates
- Oct 2012to Jun 2016
- 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 aged 18 years or older.
- Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
- Localized PoNP present for at least 3 months.
- Size of the affected painful skin area is not larger than the size of 3 plasters.
- Intact skin besides the scar of surgery in the area of plasters application
- Baseline average pain intensity of 4 or greater on the 11 point pain intensity Numeric Rating Scale.
Who cannot join
- Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial.
- Previous enrollment in this trial.
- History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment.
- Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation.
- Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
- Any surgery performed in the 3 months prior to enrollment, which may affect efficacy or safety assessment.
Show all 15Show fewer
- Any surgery scheduled or expected during the trial.
- Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator's opinion, may preclude the subject's participation in the trial.
- History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to enrollment.
- Subject with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
- Pending litigation due to chronic pain or disability.
- Total anesthesia in the cutaneous area neurologically related to the location of the surgical intervention.
- Hypersensitivity to the lidocaine 5% medicated plaster, its excipients, or anesthetics of the amide type.
- Any former use of topical lidocaine in the area of localized chronic PoNP.
- Severe renal, hepatic or heart disorder.
Trial locations and contacts
42 sites in 8 countries.
42 sites in 8 countries
France10 sites
FRA004
Amiens
FRA002
Bordeaux
FRA001
Boulogne-Billancourt
FRA003
Le Chesnay
FRA005
Lille
FRA010
Montauban
FRA006
Nantes, 44093
FRA009
Paris, 75004
FRA008
Saint-Priest-en-Jarez, 42270
FR007
Toulouse, 31059
Brazil7 sites
BRA005
Barretos, 14784-400
BRA002
Itajaí, 88301-220
BRA001
Porto Alegre, 91350-200
BR008
Salvador, 40170-150
BRA003
São Paulo, 01246-000
BRA006
São Paulo, 01323-903
BRA007
São Paulo, 04032-060
Austria6 sites
AUT004
Klagenfurt
AUT005
Senftenberg
AUT001
Vienna, 1090
AUT006
Vienna, 1100
AUT002
Vienna
AUT003
Vienna
Belgium5 sites
BEL001
Gozée
BEL006
Halen, 3545
BEL004
Ham
BEL007
Lanaken, 3620
BEL002
Natoye
United Kingdom4 sites
GBR003
Cardiff, CF14 4XW
GBR001
Glasgow, G12 0YN
GBR004
Liverpool, L9 7LJ
GBR002
Manchester, M23 9LT
Denmark3 sites
DNK005
Copenhagen, 2400
DNK004
Glostrup Municipality, 2600
DNK001
Odense
About this study
Official title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative 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.
- Conditions
- Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain
- Being tested
- Lidocaine 5% medicated plaster, Placebo plaster
- 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
Placebo plasterDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine plaster | Experimental | Topical hydrogel plaster Receives: Drug: Lidocaine 5% medicated plaster |
| Placebo plaster | Placebo comparator | Topical hydrogel plaster Receives: Drug: Placebo plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
Measured: Days 78-85
Secondary outcomes (18)
Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Measured: up to 12 weeks
Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Measured: up to 12 weeks
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Measured: up to 12 weeks
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Measured: up to 12 weeks
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Measured: Day 85
Pain intensity from mechanical dynamic allodynia (brush) testing.
Measured: Day 85
Anxiety and depression scores of HADS.
Measured: Day 85
The weighted Health Status Index of quality of life by means of EQ 5D.
Measured: Day 85
Total score in quality of sleep using CPSI.
Measured: Day 85
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Measured: up to 12 weeks
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Measured: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
Measured: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Measured: up to 12 weeks
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Measured: Day 85
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Measured: Day 85
Change from baseline in anxiety and depression scores of HADS.
Measured: Day 85
Change from baseline in total score of quality of life by means of EQ 5D.
Measured: Day 85
Change from baseline in total score in quality of sleep using CPSI.
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752322
- Sponsor's protocol ID
- KF10004/10
- Other IDs
- 2012-000347-28
- Status last verified
- Jul 2016
- First submitted
- 12 Sep 2012
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.
PubMed 30614286
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01752322
- Acronym / sponsor ID
- KF10004/10
- Conditions
- Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Dec 2012 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine plaster | Experimental | Drug: Lidocaine 5% medicated plasterTopical hydrogel plaster |
| Placebo plaster | Placebo comparator | Drug: Placebo plasterTopical hydrogel plaster |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 18 years or older.
- Subjects suffering from moderate to severe localized chronic PoNP (post operative neuropathic pain) pain following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
- Localized PoNP present for at least 3 months.
- Size of the affected painful skin area is not larger than the size of 3 plasters.
- Intact skin besides the scar of surgery in the area of plasters application
Key exclusion criteria (15 listed)
- Participation in another trial (with medicine or a device under investigation) in parallel or less than 30 days prior to enrollment in this trial.
- Previous enrollment in this trial.
- History of dependency or active drug abuse (alcohol, medication) during the 1 year prior to enrollment.
- Evidence or history (during the 3 years prior to enrollment) of neurotic personality or psychiatric illness that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subjects safety during trial participation.
- Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
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 plaster | Drug | Lidocaine plaster |
| Placebo plaster | Drug | Placebo plaster |
Primary outcome
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
Time frame: Days 78-85
18 secondary outcomes
Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Time frame: up to 12 weeks
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Time frame: up to 12 weeks
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time frame: Day 85
Pain intensity from mechanical dynamic allodynia (brush) testing.
Time frame: Day 85
Anxiety and depression scores of HADS.
Time frame: Day 85
The weighted Health Status Index of quality of life by means of EQ 5D.
Time frame: Day 85
Total score in quality of sleep using CPSI.
Time frame: Day 85
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
Time frame: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Time frame: up to 12 weeks
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time frame: Day 85
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Time frame: Day 85
Change from baseline in anxiety and depression scores of HADS.
Time frame: Day 85
Change from baseline in total score of quality of life by means of EQ 5D.
Time frame: Day 85
Change from baseline in total score in quality of sleep using CPSI.
Time frame: Day 85
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 6 Jul 2016.
- Derived from this study: PubMed 30614286Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.
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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.
Study Director study director
Grünenthal GmbH
42 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 5% medicated plaster in people with Pain and Chronic Pain, run by Grünenthal GmbH at 42 sites in 8 countries.
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 6 inclusion and 15 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France, Brazil, Austria, Belgium, Spain and 3 more countries. 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 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?
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period. (time frame: Days 78-85). 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 NCT01752322, which also lists 1 linked publication.
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 6 Jul 2016.