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Osteoporotic Fracture and Lidocaine plaster 5% for Neuropathic Pain preventioN (FLYNN)
EU CTIS ID: 2025-524889-25-00
What this study is testing
Assess the development of neuropathic pain following an osteoporotic vertebral fracture 2 months after applying a daily 5% lidocaine patch.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient (male or female) aged 50 or over, diagnosed with osteoporosis by a rheumatologist
- Patient with osteoporotic vertebral fracture, as determined by the investigator, less than 1 month old
- Patient with pain rated ≥3 on the numerical scale at the site of the vertebral fracture
- Able to give informed consent to participate in the research.
- Affiliation with a Social Security scheme.
You likely can't join if
- Patients with medical and/or surgical histories deemed by the investigator or his/her representative to be incompatible with the trial.
- Known hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
- Known hypersensitivity to other local anesthetics of the amide type, such as bupivacaine, etidocaine, mepivacaine, and prilocaine.
- Taking class I antiarrhythmic drugs (e.g., tocaine, mexiletine) or other local anesthetics.
- Inflamed or damaged skin, such as active shingles lesions, dermatitis, or wounds at the site where the patch is applied.
- 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.
See the full eligibility criteria
- Patient (male or female) aged 50 or over, diagnosed with osteoporosis by a rheumatologist
- Patient with osteoporotic vertebral fracture, as determined by the investigator, less than 1 month old
- Patient with pain rated ≥3 on the numerical scale at the site of the vertebral fracture
- Able to give informed consent to participate in the research.
- Affiliation with a Social Security scheme.
- Patients with medical and/or surgical histories deemed by the investigator or his/her representative to be incompatible with the trial.
- Known hypersensitivity to the active substance or to any of the excipients listed in the Composition section.
- Known hypersensitivity to other local anesthetics of the amide type, such as bupivacaine, etidocaine, mepivacaine, and prilocaine.
- Taking class I antiarrhythmic drugs (e.g., tocaine, mexiletine) or other local anesthetics.
- Inflamed or damaged skin, such as active shingles lesions, dermatitis, or wounds at the site where the patch is applied.
- 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.
- Patient currently participating in another clinical research protocol.
- Patient under legal protection or deprived of liberty.
- Refusal to participate.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.