idocaine 5% medicated plaster for the topical treatment of localized chronic postoperative neuropathic pain after total knee replacement or thoracotomy

Phase 1

• Conditions: localized chronic post-operative neuropathic pain (PoNP) after total knee replacement or thoracotomy (including drainage, excluding subjects with neoplasia-related thoracotomy); MedDRA version: 12.1 Level: LLT Classification code 10054095 Term: Neuropathic pain; MedDRA version: 12.1 Level: LLT Classification code 10054711 Term: Postoperative pain

• Registration Number: EUCTR2009-016337-10-FR
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-22
• Study Completion: 2012-10-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female subject aged =18 years at the Enrollment Visit (Visit 1).
2. Subjects having understood the nature of the trial and having given written informed consent.
3. Subjects able: to communicate meaningfully with investigational center staff, to comply with investigational center staff instructions, to comply with the planned use of the IMP, to complete the questionnaires, and to use the eDiaries.
4. For women of childbearing potential, a negative pregnancy test (sample taken at the Enrollment Visit [Visit 1]).
5. Subjects suffering from moderate to severe localized chronic PoNP following total knee replacement, or thoracotomy (including drainage, excluding subjects with neoplasia-related thoracotomy). Localized chronic PoNP is defined as chronic neuropathic pain in a single cutaneous area neurologically related to the site of surgery and following surgery.
6. Total knee replacement or thoracotomy was performed =24 months prior to the Enrollment Visit (Visit 1).
7. Subject assessment of the typical daily pain intensity at the Enrollment Visit (Visit 1) (NRS A_enroll) of =5 on the 11 point NRS using the provided questionnaire.
8. Daily neuropathic pain present for =6 months prior to the Enrollment Visit (Visit 1).
9. DN4 questionnaire score =4/10 (Bouhassira et al. 2005) at the Enrollment Visit (Visit 1).
10. Presence of at least one of the following neurological symptoms: allodynia, dysesthesia or hypoesthesia; being present in the same neurological area as the localized chronic PoNP at the Enrollment Visit (Visit 1) (assessment based on DN4 outcomes).
11. Size of the affected painful skin area not larger than 3 plasters.
12. Healed skin (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds, etc) in the area where the plasters will be applied.
13. Subjects without concomitant medication for neuropathic pain or subjects receiving stable treatment (unchanged doses on =5 days in 7 days over 1 month prior to the Enrollment Visit [Visit 1] and planned to be maintained stable during the trial) for neuropathic pain, or subjects using non stable treatment for neuropathic pain prior to the Enrollment Visit (Visit 1), but agreeing to stop the non stable treatment from Visit 1 until the end of the Double blind Treatment Period (Visit 4).
14. Calculated mean (NRS A_av) of the average 24 h daily pain intensities recorded in the eDiary during the Enrollment Period of =5 on the 11 point NRS (assessed at Visit 2); more than 80% of entries must be available since the Enrollment Visit (Visit 1).
15. Compliance with use (i.e., completion of assessments) by means of eDiaries; more than 80% of entries must be available since the Enrollment Visit (Visit 1) (assessed at Visit 2).
16. All laboratory values available before the Randomization Visit (Visit 2).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participation in another trial of IMPs or devices parallel to, or <1 month prior to the Enrollment Visit (Visit 1), or previous participation in this trial.
2. Any dependency of the subject to the Investigator or the trial center, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial center, as well as family members of the employees or the Investigator.
3. History of dependency or active” drug abuse during the 3 years prior to the Enrollment Visit (Visit 1).
4. Evidence or history (during the 3 years prior to the Enrollment Visit [Visit 1]) of alcohol, medication, or drug dependency.
5. Evidence or history (during the 3 years prior to the Enrollment Visit [Visit 1]) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
6. Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception. Contraception with a Pearl Index <1 is regarded as satisfactory (e.g., most oral contraceptives, intra uterine device method with hormonal supplement, or male or female condom with diaphragm and a spermicidal agent [foam, jelly, or cream]). Satisfactory contraception has not been used for =28 days prior to the Enrollment Visit (Visit 1) and patient does not agree to use it during the entire trial and until 28 days after the Final Visit (Visit 4) or the Withdrawal Visit. Women of childbearing age not counseled about the use of adequate contraception.
7. Any surgery performed in the 3 months prior to the Enrollment Visit (Visit 1) or any surgery scheduled or expected during the trial.
8. Clinically significant disease (e.g., acquired immunodeficiency syndrome), or condition (e.g., chronic inflammation in the operated area) which may affect efficacy or safety assessments, or any other reason which in Investigator’s opinion may preclude the subject’s participation in the trial.
9. Any painful procedures planned during the trial that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
10. History of malignancy (with the exception of basal cell carcinoma) within the 2 years prior to the Enrollment Visit (Visit 1).
11. Other painful conditions in the area of PoNP of infectious or non-infectious, inflammatory (e.g., arthritis) or neuropathic (e.g., neuropathies due to diabetes, chronic alcoholism, Lyme disease, acquired immunodeficiency syndrome, acute herpes zoster infection) causes, conditions representing a complication of the previous surgical procedure (e.g., intolerance to prosthetic material, hematoma), or diagnosis of complex regional pain syndrome type 1.
12. Presence of total anesthesia in the neurological area of localized chronic PoNP (test performed at Enrollment Visit [Visit 1]).
13. Thoracotomy related to neoplasia.
14. Hypersensitivity towards the IMP, its excipients, or anesthetics of the amide type, or contraindication towards the rescue medication (Ben u ron 500 mg tablets).
15. Severe cardiac impairment, e.g., New York Heart Association Class = III, myocardial infarction within the 6 months prior to the Enrollment Visit (Visit 1), and/or unstable angina pectoris.
16. Any former use of topical lidocai

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified