Trials Sponsors Conditions Drugs Pricing

Conditions

Morton's Neuroma

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (3)

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
Evaluate functional improvement based on Manchester Foot Pain and Disability Index (MFPDI)
2 weeks post injection

Study Arms (2)

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

Drug: CTNX-4975

0.6 mg of CNTX-4975

EXPERIMENTAL

Drug: CTNX-4975

Interventions

CTNX-4975Drug

Also known as: Capsaicin

0.2 mg of CNTX-49750.6 mg of CNTX-4975

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects aged \>/=18 years at the time of the Screening Visit.
Symptoms of intermetatarsal neuroma for at least 30 days prior to the Screening Visit.

Sponsors & Collaborators

Centrexion Therapeutics
Industrylead

MeSH Terms

Conditions

Morton Neuroma

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

MetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 15, 2015

Study Start

February 2014

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Clinically significant bursitis or another significant symptomatic condition in the region of or adjoining the neuroma.
The subject has more than one intermetatarsal neuroma on the foot to be injected (index foot).
Prior use of injection with a sclerosing agent such as alcohol or phenol, or prior surgery for intermetatarsal neuroma on the affected foot.
Prior injection of corticosteroid in the index foot or oral use of corticosteroids within 30 days of screening.
The subject has another painful condition that, in the judgment of the investigator, would interfere with the subject's ability to evaluate the pain and functional limitations that arise from the intermetatarsal neuroma.
Other painful foot pathology (e.g., bunion, hammertoe, plantar fasciitis, etc.) or evidence of clinically meaningful ischemia which in the opinion of the investigator would interfere with evaluation of the symptoms and functional limitations that arise from the intermetatarsal neuroma. For example, if the subject has pain from a bunion but that pain is easily distinguished by the subject from the neuroma pain, then the subject would still be a candidate for the study. Note, however, that the subject should also be able to distinguish the neuroma pain from the bunion pain in terms of foot function. In general, if another foot pain condition (in the same foot) gives rise to pain that is greater than the neuroma pain, then that subject should in most instances be excluded.
Signs of arterial insufficiency in the feet.
Ulcer and/or wound in the foot affected by the neuroma.
Active cutaneous disease, or other anatomical or physiological foot disorder, at the anticipated site of study drug injection.
History of clearly documented allergic reaction to local anesthetics or capsaicin.
Presence of any medical condition or instability that, in the judgment of the Investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease.
Clinically significant laboratory result at the Screening Visit (in the opinion of the Investigator).
Has diabetic neuropathy or other length dependent neuropathy.
Use of any investigational medication in the 30 days prior to the current study, is scheduled to receive such an agent while participating in this study, or received a topical or injected investigational medication in the index foot within the past 60 days.
Use of topical medication on the index foot within 7 days of screening (including lidocaine or capsaicin).
+3 more criteria

Study to Evaluate the Safety and Tolerability of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (2)

0.2 mg of CNTX-4975

0.6 mg of CNTX-4975

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (2)

0.2 mg of CNTX-4975

0.6 mg of CNTX-4975

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record