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

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ClinicalTrials.gov Identifier: NCT03124407
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : March 30, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Palm Beach Research, Inc
Information provided by (Responsible Party):
Propella Therapeutics

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Capsaicin Topical Solution Other: Drug product vehicle Phase 4

Detailed Description:

This is a study of a 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. Both knees received study drug treatment but only one knee per subject was assigned as the "study knee".

Osteoarthritis knee pain was assessed by the 100 mm visual analog scale and the response criterion was a 50% or greater reduction in osteoarthritis knee pain from baseline. Baseline was defined as the visual analog scale recorded not more than 30 minutes before the first study drug application (on Study Day 1). For subjects in the once daily (QD) groups the osteoarthritis knee pain assessments were at 12 hrs after the initial application (during Study Day 1) and 24 hours (Study Day 2) after the initial application and then once in the morning on Study Days 3 - 28. For subjects in the twice daily (BID) groups the osteoarthritis knee pain assessments were at 12 hrs after the initial application (during Study Day 1) and 24 hours(Study Day 2) after the initial application and then once in the morning and once 12 hours later on Study Days 3 - 28.

Tolerability data were also collected as reported burning-stinging pain, erythema and pruritus at the site of application.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active treatment compared to drug vehicle as placebo
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study medications were number coded only and identical in physical characteristics. Randomization coding was held only at the manufacturing site until data base lock.
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Dose, Placebo-Controlled Pain Relief Study of 0.25% 920-CGS-200 in Subjects With Preexisting Knee Pain (for at Least 6 Months) Caused by Osteoarthritis (OA)
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: Once daily-Active
40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee
Drug: Capsaicin Topical Solution
Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

Placebo Comparator: Once daily-Vehicle
20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee
Other: Drug product vehicle
This is the vehicle for the active treatment drug product, but without capsaicin

Active Comparator: Twice daily-Active
40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee
Drug: Capsaicin Topical Solution
Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin

Placebo Comparator: Twice daily-Vehicle
20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee
Other: Drug product vehicle
This is the vehicle for the active treatment drug product, but without capsaicin




Primary Outcome Measures :
  1. Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to 24 Hours After First Dose of Study Drug Treatment. [ Time Frame: Study Day 2 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 8 Post Study Drug Treatment. [ Time Frame: Study Days 1-7 ]
    To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after a 7 day period. 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.

  2. Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment. [ Time Frame: Study Days 1-28 ]
    To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after 28 days. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has granted written informed consent.
  2. Subject is at least 18 years of age.
  3. Subject has knee pain with radiographic evidence of osteoarthritis in at least one knee (including an x-ray within the previous 2 years).
  4. Subject's osteoarthritis knee pain has been present for ≥ 6 months.
  5. Subject has osteoarthritis knee pain of ≥ 50 mm in one knee based on the visual analog scale at screening.
  6. 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.
  7. 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.
  8. Subject is capable of understanding and complying with all instructions and study procedures, including the ability to accurately evaluate their symptoms.
  9. 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.

Exclusion Criteria:

  1. Subject has spontaneously improving or rapidly deteriorating osteoarthritis or knee pain.
  2. Subject has rheumatoid or psoriatic arthritis, or a form of arthritis inconsistent with a diagnosis of osteoarthritis.
  3. 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.
  4. Subject is currently taking prescription pain medication.
  5. Subject has shaved their knees within 2 days of first day of treatment (Day 1).
  6. 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).
  7. 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).
  8. Subject has used topical therapy on the knees that, in the investigator's opinion, might affect the study evaluations of signs and/or symptoms.
  9. Subject has broken or damaged skin on their knees, or an open wound near the knees.
  10. Subject has a history of allergy/sensitivity to topical substances.
  11. Subject is not able to understand the nature, importance, or consequences of the study.
  12. 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.
  13. 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.
  14. Is obese with a Body Mass Index (BMI) of greater than 40 kg/m2.
  15. Subject requires a surgical procedure in the immediate future.
  16. Subject is pregnant or nursing.
  17. Subject has been treated with an investigational drug, device, or therapy within 30 days prior to first day of treatment (Day 1).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124407


Locations
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United States, Florida
Research Center
Clearwater, Florida, United States
Research Center
Tampa, Florida, United States
United States, Texas
Research Center
Dallas, Texas, United States
Sponsors and Collaborators
Propella Therapeutics
Palm Beach Research, Inc
Investigators
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Study Director: Alan A Ryan, Ph.D. Palm Beach Research, Inc
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Responsible Party: Propella Therapeutics
ClinicalTrials.gov Identifier: NCT03124407    
Other Study ID Numbers: VZU-00022
First Posted: April 21, 2017    Key Record Dates
Results First Posted: March 30, 2020
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Propella Therapeutics:
knee pain, capsaicin, topical, osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs