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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000347-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine plaster | Experimental | Topical hydrogel plaster |
|
| Placebo plaster | Placebo Comparator | Topical hydrogel plaster |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 5% medicated plaster | Drug |
| ||
| Placebo plaster |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 78-85 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUT004 | Klagenfurt | Austria | ||||
| AUT005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30614286 | Derived | 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. |
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|
| up to 12 weeks |
| Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours. | up to 12 weeks |
| Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal. | up to 12 weeks |
| Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. | Day 85 |
| Pain intensity from mechanical dynamic allodynia (brush) testing. | Day 85 |
| Anxiety and depression scores of HADS. | Day 85 |
| The weighted Health Status Index of quality of life by means of EQ 5D. | Day 85 |
| Total score in quality of sleep using CPSI. | 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. | 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. | 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. | up to 12 weeks |
| Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal. | up to 12 weeks |
| Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. | Day 85 |
| Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing. | Day 85 |
| Change from baseline in anxiety and depression scores of HADS. | Day 85 |
| Change from baseline in total score of quality of life by means of EQ 5D. | Day 85 |
| Change from baseline in total score in quality of sleep using CPSI. | Day 85 |
| Senftenberg |
| Austria |
| AUT001 | Vienna | 1090 | Austria |
| AUT006 | Vienna | 1100 | Austria |
| AUT002 | Vienna | Austria |
| AUT003 | Vienna | Austria |
| BEL001 | Gozée | Belgium |
| BEL006 | Halen | 3545 | Belgium |
| BEL004 | Ham | Belgium |
| BEL007 | Lanaken | 3620 | Belgium |
| BEL002 | Natoye | Belgium |
| BRA005 | Barretos | 14784-400 | Brazil |
| BRA002 | Itajaí | 88301-220 | Brazil |
| BRA001 | Porto Alegre | 91350-200 | Brazil |
| BR008 | Salvador | 40170-150 | Brazil |
| BRA003 | São Paulo | 01246-000 | Brazil |
| BRA006 | São Paulo | 01323-903 | Brazil |
| BRA007 | São Paulo | 04032-060 | Brazil |
| DNK005 | Copenhagen | 2400 | Denmark |
| DNK004 | Glostrup Municipality | 2600 | Denmark |
| DNK001 | Odense | Denmark |
| FRA004 | Amiens | France |
| FRA002 | Bordeaux | France |
| FRA001 | Boulogne-Billancourt | France |
| FRA003 | Le Chesnay | France |
| FRA005 | Lille | France |
| FRA010 | Montauban | France |
| FRA006 | Nantes | 44093 | France |
| FRA009 | Paris | 75004 | France |
| FRA008 | Saint-Priest-en-Jarez | 42270 | France |
| FR007 | Toulouse | 31059 | France |
| ITA004 | Florence | Italy |
| ITA003 | Naples | Italy |
| ITA001 | Rome | Italy |
| ESP001 | Barcelona | Spain |
| ESP002 | Barcelona | Spain |
| ESP006 | Madrid | 28041 | Spain |
| ESP005 | Madrid | Spain |
| GBR003 | Cardiff | CF14 4XW | United Kingdom |
| GBR001 | Glasgow | G12 0YN | United Kingdom |
| GBR004 | Liverpool | L9 7LJ | United Kingdom |
| GBR002 | Manchester | M23 9LT | United Kingdom |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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