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The purpose of this study is to confirm that the local anesthetic applied to subjects with Morton's Neuroma satisfactorily mitigates procedure pain and ensures that post-procedure discomfort or pain will not result in bias or breaking of the blind in the planned Phase 2b study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2 mg of CNTX-4975 | Experimental | CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.1 to 0.2 mg/ml |
|
| 0.6 mg of CNTX-4975 | Experimental | CNTX-4975 will be provided at a capsaicin concentration of 2.0 mg/ml and will be diluted to final concentration using sterile water and 30% PEG 300. Dose volume 1.0 mL-2.0 mL will be used at the discretion of the investigator. Capsaicin concentration will be 0.3 to 0.6 mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTNX-4975 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of a single injection of CNTX-4975 through assessment of incidence, intensity, relationship and seriousness of treatment-emergent adverse events | up to 6 months post injection | |
| Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in vital signs and laboratory tests | blood pressure, hart rate, respiration rate, body temperature, weight | up to 2 weeks post injection |
| Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes in sensory and motor examination of the foot | Light touch and pin prick of toes in both feet and evaluation of flexion and extension ability | up to 6 months post injection |
| Evaluate the safety and tolerability of a single injection of CNTX-4975 through treatment-emergent changes at injection site by Injection site assessment 5-point scale for erythema and edema | 1, 2, and 4 hours post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the magnitude and duration of analgesic efficacy of CNTX-4975 using Numeric Pain Rating Scale (NPRS, 0-10 scale) | Up to 6 months post injection | |
| Evaluate Patient Global Impression of Change (PGIC) | Up to 6 months post injection |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Evaluate functional improvement based on Manchester Foot Pain and Disability Index (MFPDI) | 2 weeks post injection |
| D009437 |
| Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |