Osteoporotic Fracture and Lidocaine plaster 5% for Neuropathic Pain preventioN (FLYNN)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-06-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assess the development of neuropathic pain following an osteoporotic vertebral fracture 2 months after applying a daily 5% lidocaine patch.

Secondary objectives 5

1. Evaluate compliance and monitoring of adverse effects following an osteoporotic vertebral fracture 2 months after the application of a daily 5% lidocaine patch.
2. Compare between groups with and without daily application of 5% lidocaine patch: - Pain after 2 months of treatment
3. Compare between groups with and without daily application of 5% lidocaine patch: o Concomitant treatments
4. Compare between groups with and without daily application of 5% lidocaine patch: o Quality of life and sleep
5. Characterize pain psychophysically in patients who are neuropathic after 2 months of treatment and compare between the two randomization groups.

Conditions and MedDRA coding

Osteoporotic Fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient (male or female) aged 50 or over, diagnosed with osteoporosis by a rheumatologist
2. Patient with osteoporotic vertebral fracture, as determined by the investigator, less than 1 month old
3. Patient with pain rated ≥3 on the numerical scale at the site of the vertebral fracture
4. Able to give informed consent to participate in the research.
5. Affiliation with a Social Security scheme.

Exclusion criteria 9

1. Patients with medical and/or surgical histories deemed by the investigator or his/her representative to be incompatible with the trial.
2. Known hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
3. Known hypersensitivity to other local anesthetics of the amide type, such as bupivacaine, etidocaine, mepivacaine, and prilocaine.
4. Taking class I antiarrhythmic drugs (e.g., tocaine, mexiletine) or other local anesthetics.
5. Inflamed or damaged skin, such as active shingles lesions, dermatitis, or wounds at the site where the patch is applied.
6. Pregnant and breastfeeding women (A pregnancy test will be performed for women of childbearing age in accordance with CTCG guidelines (see APPENDIX X). The investigator will ensure that effective contraception is used while the lidocaine patch is being used.
7. Patient currently participating in another clinical research protocol.
8. Patient under legal protection or deprived of liberty.
9. Refusal to participate.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Onset of neuropathic pain 2 months after enrollment, as a percentage of patients, using the Pain Detect Questionnaire (score ≥19).

Secondary endpoints 5

1. Adverse effects and compliance in the daily logbook
2. Pain assessment (numerical scale) after 2 months of treatment
3. Concomitant treatments
4. Quality of life of patients according to SF36 and sleep according to PSQI
5. Psychophysical assessment in neuropathic patients

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont Ferrand Cedex 1

Postcode

63003

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications