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A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis

Phase 1
Waitlist Available
Research Sponsored by Centrexion Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose to 3 hours post-dose) or day 8 (pre-dose to 3 hours post-dose) [cross over trial qutenza® 8% patch or cntx-4975-05 ia knee injection]
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose to 3 hours post-dose) or day 8 (pre-dose to 3 hours post-dose) [cross over trial qutenza® 8% patch or cntx-4975-05 ia knee injection]
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose to 3 hours post-dose) or day 8 (pre-dose to 3 hours post-dose) [cross over trial qutenza® 8% patch or cntx-4975-05 ia knee injection] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Capsaicin Pharmacokinetics - AUC0-inf
Capsaicin Pharmacokinetics - AUC0-t
Capsaicin Pharmacokinetics - Cmax
Secondary study objectives
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CNTX-4975-05 Intra-Articular (IA) InjectionExperimental Treatment2 Interventions
Receives IA injection into the most painful OA knee.
Group II: Topical 8% Capsaicin PatchActive Control1 Intervention
Receives Capsaicin Patch on posterior rib cage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine (without epinephrine)
2018
Completed Phase 1
~20
Capsaicin
FDA approved

Find a Location

Who is running the clinical trial?

Centrexion TherapeuticsLead Sponsor
13 Previous Clinical Trials
2,141 Total Patients Enrolled
6 Trials studying Osteoarthritis
1,767 Patients Enrolled for Osteoarthritis
Randall Stevens, MDStudy ChairCentrexion Therapeutics
2 Previous Clinical Trials
378 Total Patients Enrolled
1 Trials studying Osteoarthritis
332 Patients Enrolled for Osteoarthritis
~2 spots leftby Dec 2025
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