Efficacy and Tolerability of Lidocaine Plaster for Treatment of Long-term Local Nerve Pain

• Sponsor: Grünenthal GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01752322
• Collaborator: (none)
• Enrollment: 444
• Locations: 42
• Arms: 2
• Duration (Months): 44
• Patients Per Site: 10.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Chronic Pain; Neuropathic Pain; Postoperative Pain	Drug: Lidocaine 5% medicated plaster; Drug: Placebo plaster	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 444 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine plaster Topical hydrogel plaster	Drug: Lidocaine 5% medicated plaster
Placebo Comparator: Placebo plaster Topical hydrogel plaster	Drug: Placebo plaster

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

2. 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. [up to 12 weeks]

3. Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours. [up to 12 weeks]

4. Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal. [up to 12 weeks]

5. Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [Day 85]

6. Pain intensity from mechanical dynamic allodynia (brush) testing. [Day 85]

7. Anxiety and depression scores of HADS. [Day 85]

8. The weighted Health Status Index of quality of life by means of EQ 5D. [Day 85]

9. Total score in quality of sleep using CPSI. [Day 85]

10. 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]

11. 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]

12. 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]

13. Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal. [up to 12 weeks]

14. Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period. [Day 85]

15. Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing. [Day 85]

16. Change from baseline in anxiety and depression scores of HADS. [Day 85]

17. Change from baseline in total score of quality of life by means of EQ 5D. [Day 85]

18. Change from baseline in total score in quality of sleep using CPSI. [Day 85]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AUT004	Klagenfurt		Austria
2	AUT005	Senftenberg		Austria
3	AUT006	Vienna		Austria	1100
4	AUT002	Vienna		Austria
5	AUT003	Vienna		Austria
6	AUT001	Wien		Austria	1090
7	BEL001	Gozée		Belgium
8	BEL006	Halen		Belgium	3545
9	BEL004	Ham		Belgium
10	BEL007	Lanaken		Belgium	3620
11	BEL002	Natoye		Belgium
12	BRA005	Barretos		Brazil	14784-400
13	BRA002	Itajai		Brazil	88301-220
14	BRA001	Porto Alegre		Brazil	91350-200
15	BR008	Salvador		Brazil	40170-150
16	BRA003	Sao Paulo		Brazil	01246-000
17	BRA006	São Paulo		Brazil	01323-903
18	BRA007	São Paulo		Brazil	04032-060
19	DNK005	Copenhagen		Denmark	2400
20	DNK004	Glostrup		Denmark	2600
21	DNK001	Odense		Denmark
22	FRA004	Amiens		France
23	FRA002	Bordeaux		France
24	FRA001	Boulogne Billancourt		France
25	FRA003	Le Chesnay		France
26	FRA005	Lille		France
27	FRA010	Montauban		France
28	FRA006	Nantes		France	44093
29	FRA009	Paris		France	75004
30	FRA008	Saint-Priest en Jarez		France	42270
31	FR007	Toulouse		France	31059
32	ITA004	Firenze		Italy
33	ITA003	Napoli		Italy
34	ITA001	Rome		Italy
35	ESP001	Barcelona		Spain
36	ESP002	Barcelona		Spain
37	ESP006	Madrid		Spain	28041
38	ESP005	Madrid		Spain
39	GBR003	Cardiff		United Kingdom	CF14 4XW
40	GBR001	Glasgow		United Kingdom	G12 0YN
41	GBR004	Liverpool		United Kingdom	L9 7LJ
42	GBR002	Manchester		United Kingdom	M23 9LT

Sponsors and Collaborators

• Grünenthal GmbH

Investigators

• Study Director: Study Director, Grünenthal GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grünenthal GmbH
• ClinicalTrials.gov Identifier: NCT01752322
• Other Study ID Numbers: KF10004/10; 2012-000347-28
• First Posted: Dec 19, 2012
• Last Update Posted: Jul 6, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Neuralgia; Chronic Pain; Lidocaine

Study Results

No Results Posted as of Jul 6, 2016