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Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200

NCT03124407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-31

Study results available
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Summary

This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs) Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion criteria were randomized into one of four groups: once daily treatment with active product, once daily treatment with product vehicle (no capsaicin), twice daily treatment with active product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive days of treatment. The twice daily treatments were spaced approximately 12 hours apart. Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee pain assessments were done each day for 28 days. Tolerability data were also collected.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Capsaicin Topical Solution

Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

OTHER

Drug product vehicle

This is the vehicle for the active treatment drug product, but without capsaicin

Sponsors & Collaborators

  • Palm Beach Research, Inc

    collaborator UNKNOWN

  • Propella Therapeutics

    lead INDUSTRY

Principal Investigators

  • Alan A Ryan, Ph.D. · Palm Beach Research, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-10-31
Completion
2016-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03124407 on ClinicalTrials.gov