Osteoarthritis, KneePhase 4NCT03124407
Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200
A Phase 4 study testing Capsaicin Topical Solution in people with Osteoarthritis, Knee, run by Propella Therapeutics at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Capsaicin Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Subject is pregnant or nursing.
- Subject has been treated with an investigational drug, device, or therapy within 30 days prior to first day of treatment (Day 1).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Center
Clearwater, Florida
Research Center
Dallas, Texas
Research Center
Tampa, Florida
About this study
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)
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Capsaicin Topical Solution, Drug product vehicle
- Keywords
- knee pain, capsaicin, topical, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Topical SolutionDrug
Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin
Drug product vehicleOther
This is the vehicle for the active treatment drug product, but without capsaicin
| Study group | Role | What they receive |
|---|---|---|
| Once daily-Active | Active comparator | 40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee Receives: 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 Receives: 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 Receives: 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 Receives: Other: Drug product vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Study Days 1-7
Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment.
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.
Measured: Study Days 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active treatment compared to drug vehicle as placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Propella Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palm Beach Research, Inc
- Responsible party
- Sponsor
- Investigators
- Alan A Ryan, Ph.D., Study director, Palm Beach Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124407
- Sponsor's protocol ID
- VZU-00022
- Status last verified
- Oct 2020
- First submitted
- 18 Apr 2017
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03124407
- Acronym / sponsor ID
- VZU-00022
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee pain, capsaicin, topical, osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Propella TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Palm Beach Research, Inc
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Active treatment compared to drug vehicle as placebo
| Arm | Type | Receives |
|---|---|---|
| Once daily-Active | Active comparator | Drug: Capsaicin Topical Solution40 subjects receiving once daily application of complete drug product (contains 0.25% capsaicin) to the knee |
| Once daily-Vehicle | Placebo comparator | Other: Drug product vehicle20 subjects receiving once daily application of drug product vehicle (i.e., with no capsaicin) to the knee |
| Twice daily-Active | Active comparator | Drug: Capsaicin Topical Solution40 subjects receiving twice daily application of complete drug product (contains 0.25% capsaicin) to the knee |
| Twice daily-Vehicle | Placebo comparator | Other: Drug product vehicle20 subjects receiving twice daily application of drug product vehicle (i.e., with no capsaicin) to the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin Topical SolutionOver-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin | Drug | Once daily-Active, Twice daily-Active |
| Drug product vehicleThis is the vehicle for the active treatment drug product, but without capsaicin | Other | Once daily-Vehicle, Twice daily-Vehicle |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan A Ryan, Ph.D. study director
Palm Beach Research, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Capsaicin Topical Solution in people with Osteoarthritis, Knee, run by Propella Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.