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

NCT03124407 | Completed Phase 4 Results FDA Drug

• 1 other identifier: VZU-00022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

knee pain, capsaicin, topical, osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to 24 Hours After First Dose of Study Drug Treatment.

  To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline at 24 hours following the first study drug treatment. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.

  Study Day 2

Secondary Outcomes (2)

• Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 8 Post Study Drug Treatment.

  Study Days 1-7

• Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment.

  Study Days 1-28

Study Arms (4)

Once daily-Active

ACTIVE COMPARATOR

40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee

Drug: Capsaicin Topical Solution

Once daily-Vehicle

PLACEBO COMPARATOR

20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee

Other: Drug product vehicle

Twice daily-Active

ACTIVE COMPARATOR

40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee

Drug: Capsaicin Topical Solution

Twice daily-Vehicle

PLACEBO COMPARATOR

20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee

Other: Drug product vehicle

Interventions

Capsaicin Topical Solution DRUG

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

Once daily-Active; Twice daily-Active

Drug product vehicle OTHER

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

Once daily-Vehicle; Twice daily-Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has granted written informed consent.
• Subject is at least 18 years of age.
• Subject has knee pain with radiographic evidence of osteoarthritis in at least one knee (including an x-ray within the previous 2 years).
• Subject's osteoarthritis knee pain has been present for ≥ 6 months.
• Subject has osteoarthritis knee pain of ≥ 50 mm in one knee based on the visual analog scale at screening.
• Subject has regularly used topical over-the-counter pain relief products or over-the-counter oral medication (acetaminophen or ibuprofen) to treat/manage pain from osteoarthritis in the previous 3 months.
• Subject is in good general health and free of any disease state or physical condition which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
• Subject is capable of understanding and complying with all instructions and study procedures, including the ability to accurately evaluate their symptoms.
• Subject must be a male or non-pregnant female. If female, subject must be past childbearing age or otherwise must test negative for pregnancy. Males and females must agree to use effective birth control during the study or for at least 30 days after last dose of study investigational product, if unable to complete the study.

You may not qualify if:

• Subject has spontaneously improving or rapidly deteriorating osteoarthritis or knee pain.
• Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent with a diagnosis of osteoarthritis.
• Subject has used any topical steroids on or in the vicinity of the knees within 1 week prior to Screening, or has had a knee injection within 1 month prior to Screening.
• Subject is currently taking prescription pain medication.
• Subject has shaved their knees within 2 days of first day of treatment (Day 1).
• Subject has used any capsaicin containing product on or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day 1).
• Subject has used any topically applied products (including emollient/moisturizer) on or in the vicinity of the knees within 2 weeks prior to first day of treatment (Day 1).
• Subject has used topical therapy on the knees that, in the investigator's opinion, might affect the study evaluations of signs and/or symptoms.
• Subject has broken or damaged skin on their knees, or an open wound near the knees.
• Subject has a history of allergy/sensitivity to topical substances.
• Subject is not able to understand the nature, importance, or consequences of the study.
• Subject has a psychiatric disorder or has significant anxiety or depression that, in the investigator's opinion, could interfere with the subject's ability to accurately assess their pain, adhere to study instructions, or complete the study.
• Subject has hypertension that is not adequately controlled (medication to treat hypertension is allowed), vascular disease, psychological disorder, or other condition that, in the investigator's opinion, contraindicate the use of medication.
• Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.
• Subject requires a surgical procedure in the immediate future.

Sponsors & Collaborators

• Propella Therapeutics: lead
• Palm Beach Research, Inc: collaborator

Study Sites (3)

Research Center

Clearwater, Florida, United States

Location

Research Center

Tampa, Florida, United States

Location

Research Center

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: Vizuri Health Sciences

twarneke@vizuriusa.com

919-397-4782

Study Officials

• Alan A Ryan, Ph.D.

  Palm Beach Research, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study medications were number coded only and identical in physical characteristics. Randomization coding was held only at the manufacturing site until data base lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active treatment compared to drug vehicle as placebo

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 31, 2024
• Results First Posted: March 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)