Osteoarthritis, KneePhase 2NCT05007808
Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
A Phase 2 study testing G001 Topical Gel in people with Osteoarthritis, Knee, run by BUZZZ Pharmaceuticals Limited at 10 sites in Canada.
Trial summary
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- G001 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 10 sitesCanada
- Study dates
- 6 Jan 2021to 10 Jan 2023
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of OA of the knee, meeting American College of Rheumatology (ACR) criteria for classification of idiopathic (primary) OA for at least 6 months prior to Screening
- Radiologic evidence of OA of the knee of grade 2 (mild) or grade 3 (moderate) according to Kellgren and Lawrence Radiographic Grading
- Worst daily pain (within 24 hours prior to Screening and Baseline) in the index knee between 4 and 8 on the 11-point pain NRS
- On stable analgesic therapy
- At Baseline:
- Development of a flare of pain following washout of stable analgesic (NSAID and/or acetaminophen) therapy
Who cannot join
- Radiologic evidence of severe OA of the knee (Kellgren and Lawrence grade 4)
- Secondary OA of the index knee
- Any other arthritis, included but not limited to rheumatoid arthritis, psoriatic arthritis, etc.
- History of pseudo-gout or inflammatory flare-ups
- History of severe neurological conditions
- Any other chronic pain conditions (e.g., back pain) or disabling conditions affecting the joints
Show all 20Show fewer
- Patients who are non-ambulatory or require the use of crutches or a walker, or started using a cane within 30 days prior to Screening
- Any history of major surgery to the index knee, minor knee surgery, or injury to the index knee within 1 year prior to Screening
- Knee arthroscopy (index knee) within 3 months prior to Screening
- Planned or candidate for knee replacement or knee reconstruction surgery
- Received intra-articular viscosupplementation/hyaluronate, joint lavage, or other invasive therapies to the index knee in the past 90 days
- Treatment with or need for any of the following: (1) oral or intramuscular corticosteroids within the past 90 days; (2) intra-articular corticosteroid injection into the index knee within the past 90 days, or into any other joint within the past 30 days; (3) current use of topical corticosteroids on the index knee
- Prior stable therapy with an opioid analgesic, or anticipated need for opioid analgesic use during the study
- Use of sedative hypnotic medication, antidepressants with known analgesic effect, antipsychotics, antiepileptics, and anti-Parkinson drugs within the past 14 days
- Regular use of medication for headaches
- Anticipated use of any oral or topical NSAID (apart from the study drug) during the study
- Known sensitivity to the study drug (or any of its ingredients), or NSAIDs, or presence of contraindications, warnings, or precautions
- At Baseline:
- Worst daily pain (within the past 24 hours) in the contralateral knee assessed as >2 on the 11-point pain NRS scale
- Non-compliance with the daily diary requirement during the Screening period.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Aggarwal and Associates Limited
Brampton
Medicor Research Inc.
Greater Sudbury
Manna Research
Lévis
Recherche GCP Research
Montreal
Alpha recherche Clinique (1)
Québec
Alpha Recherche Clinique (2)
Québec
Centre de Recherche Saint-Louis
Québec
G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc.
Québec
Recherche Clinique Sigma Inc.
Québec
Canadian Phase Onward Inc.
Toronto
About this study
Official title: Phase 2 Multicenter, Double-blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy, Safety, and Local Tolerability of G001 in Patients With Osteoarthritis (OA) of the Knee
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee.
Each patient's participation is approximately 7 weeks (~1 week screening, 4 weeks of treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1.
Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain in their daily diary, as well as to document all study drug applications and any rescue medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and within approximately 2 weeks after the last study drug application for end-of-study evaluations.
- Conditions
- Osteoarthritis, Knee
- Being tested
- G001 Topical Gel, Vehicle
- Keywords
- osteoarthritis, knee, topical therapy, pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G001 Topical GelDrug
Non-steroidal anti-inflammatory drug for topical administration
VehicleDrug
Vehicle Gel for topical administration
| Study group | Role | What they receive |
|---|---|---|
| G001 Topical Gel | Experimental | G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. Receives: Drug: G001 Topical Gel |
| Vehicle Topical Gel | Placebo comparator | Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)
Measured: Week 4
Secondary outcomes (15)
Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings
Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome
Measured: Week 4
Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings
Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome
Measured: Week 4
Percent Reduction From Baseline in Worst Daytime Pain
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT
Measured: Week 4
Percent Reduction From Baseline in Worst Nighttime Pain
Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT
Measured: Week 4
Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT
WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome)
Measured: Week 4
Change From Baseline in WOMAC Total Score at Week 4/EOT
WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome)
Measured: Week 4
Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT
WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome)
Measured: Week 4
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
Change from Baseline to Week 2 in:
WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)
Measured: Week 2
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in:
WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)
Measured: Week 4 to Week 5
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome.
Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules:
Improved - defined as either of the following:
- For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline
- For baseline Grade = 1: a change in grade from 1 to 0
Worsened - defined as either of the following:
- For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline
- For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Measured: Weeks 2, 4 and 5
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome.
Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules:
Improved - defined as either of the following:
- For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline
- For baseline Grade = 1: a change in grade from 1 to 0
Worsened - defined as either of the following:
- For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline
- For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened
Measured: Weeks 2, 4 and 5
PGA of Overall Treatment Benefit (OTB)
PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.
Measured: Weeks 2 and 4
IGA of Overall Treatment Benefit (OTB)
IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.
Measured: Weeks 2 and 4
Rescue Medication Use
Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.
Measured: 5 weeks
Number of Rescue Medication Doses
Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start6 Jan 2021
- Primary completion4 Jan 2023
- Study completion10 Jan 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- BUZZZ Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Responsible party
- Sponsor
- Investigators
- Deirdre O'Keeffe, PhD, Study director, Buzzz Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007808
- Sponsor's protocol ID
- 2020-G001-P2
- Status last verified
- Mar 2024
- First submitted
- 22 Jul 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter, Double-blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy, Safety, and Local Tolerability of G001 in Patients With Osteoarthritis (OA) of the Knee
- ClinicalTrials.gov ID
- NCT05007808
- Acronym / sponsor ID
- 2020-G001-P2
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, topical therapy, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- BUZZZ Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee.
Each patient's participation is approximately 7 weeks (~1 week screening, 4 weeks of treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1.
Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain in their daily diary, as well as to document all study drug applications and any rescue medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and within approximately 2 weeks after the last study drug application for end-of-study evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G001 Topical Gel | Experimental | Drug: G001 Topical GelG001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
| Vehicle Topical Gel | Placebo comparator | Drug: VehicleVehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of OA of the knee, meeting American College of Rheumatology (ACR) criteria for classification of idiopathic (primary) OA for at least 6 months prior to Screening
- Radiologic evidence of OA of the knee of grade 2 (mild) or grade 3 (moderate) according to Kellgren and Lawrence Radiographic Grading
- Worst daily pain (within 24 hours prior to Screening and Baseline) in the index knee between 4 and 8 on the 11-point pain NRS
- On stable analgesic therapy
- Development of a flare of pain following washout of stable analgesic (NSAID and/or acetaminophen) therapy
Key exclusion criteria (20 listed)
- Radiologic evidence of severe OA of the knee (Kellgren and Lawrence grade 4)
- Secondary OA of the index knee
- Any other arthritis, included but not limited to rheumatoid arthritis, psoriatic arthritis, etc.
- History of pseudo-gout or inflammatory flare-ups
- History of severe neurological conditions
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 |
|---|---|---|
| G001 Topical GelNon-steroidal anti-inflammatory drug for topical administration | Drug | G001 Topical Gel |
| VehicleVehicle Gel for topical administration | Drug | Vehicle Topical Gel |
Primary outcome
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
Time frame: Week 4
Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)
15 secondary outcomes
Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings
Time frame: Week 4
Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings
Time frame: Week 4
Percent Reduction From Baseline in Worst Daytime Pain
Time frame: Week 4
Percent Reduction From Baseline in Worst Nighttime Pain
Time frame: Week 4
Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT
Time frame: Week 4
Change From Baseline in WOMAC Total Score at Week 4/EOT
Time frame: Week 4
Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT
Time frame: Week 4
Change From Baseline in WOMAC Total and Subscale Scores at Week 2
Time frame: Week 2
Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores
Time frame: Week 4 to Week 5
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
Time frame: Weeks 2, 4 and 5
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
Time frame: Weeks 2, 4 and 5
PGA of Overall Treatment Benefit (OTB)
Time frame: Weeks 2 and 4
IGA of Overall Treatment Benefit (OTB)
Time frame: Weeks 2 and 4
Rescue Medication Use
Time frame: 5 weeks
Number of Rescue Medication Doses
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Deirdre O'Keeffe, PhD study director
Buzzz Pharma
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G001 Topical Gel in people with Osteoarthritis, Knee, run by BUZZZ Pharmaceuticals Limited at 10 sites in Canada.
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 6 inclusion and 20 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Apr 2024). 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?
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT (time frame: Week 4). 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 23 Apr 2024.