Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: G001 Topical Gel G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
Drug: G001 Topical Gel
Non-steroidal anti-inflammatory drug for topical administration
|
| Placebo Comparator: Vehicle Topical Gel Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks. |
Drug: Vehicle
Vehicle Gel for topical administration
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in WOMAC Pain Subscale Score [Week 4]
0-20 scale, with higher scores indicating worse outcome
Secondary Outcome Measures
- Change from Baseline in WOMAC Physical Function Subscale score [Week 4]
0-68 scale, with higher scores indicating worse outcome
- Change from Baseline in WOMAC Total score [Week 4]
0-96 scale, with higher scores indicating worse outcome
- Change from Baseline in WOMAC Stiffness Subscale score [Week 4]
0-8 scale, with higher scores indicating worse outcome
- Change from Baseline in WOMAC Total and Subscale Scores [Week 2]
- Change from Week 4 to Week 5 in WOMAC Total and Subscale Scores [Week 4 to Week 5]
- Worst daily and nightly pain severity scores (11-point pain NRS) from patient diary [Weeks 4 and 5]
0-10 scale, with higher scores indicating worse outcome
- Change from Baseline in Patient Global Assessment (PGA) of disease activity over time [Weeks 2, 4 and 5]
0-4 scale, with higher scores indicating worse outcome
- Change from Baseline in Investigator Global Assessment (IGA) of disease activity over time [Weeks 2, 4 and 5]
0-4 scale, with higher scores indicating worse outcome
- PGA of overall treatment benefit [Weeks 2 and 4]
0-4 scale, with higher scores indicating worse outcome
- IGA of overall treatment benefit [Weeks 2 and 4]
0-4 scale, with higher scores indicating worse outcome
- Rescue medication use [5 weeks]
Other Outcome Measures
- Frequency and severity of adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation [6 weeks]
Number and percentage of participants with AEs
- Frequency and severity of application site AEs [5 weeks]
Number and percentage of participants with application site AEs
- Skin irritation test scores [Weeks 2, 4, and 6]
0-10 scale, with higher scores indicating worse outcome
- Changes from baseline in safety laboratory test results [6 weeks]
Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges
- Changes in vital signs measurements [6 weeks]
Mean changes (descriptive) from baseline
- Changes in physical examination [6 weeks]
Number and percentage of participants with clinically significant abnormal findings
- ECG QT interval [4 weeks]
Number and percentage of participants with clinically significant abnormal results
- ECG QTc interval [4 weeks]
Number and percentage of participants with clinically significant abnormal results
- ECG QRS interval [4 weeks]
Number and percentage of participants with clinically significant abnormal results
- ECG PR interval [4 weeks]
Number and percentage of participants with clinically significant abnormal results
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aggarwal and Associates Limited | Brampton | Canada | ||
| 2 | Manna Research | Lévis | Canada | ||
| 3 | Recherche GCP Research | Montréal | Canada | ||
| 4 | Alpha recherche Clinique (1) | Quebec City | Canada | ||
| 5 | Alpha Recherche Clinique (2) | Quebec City | Canada | ||
| 6 | Centre de Recherche Saint-Louis | Quebec City | Canada | ||
| 7 | G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc. | Quebec City | Canada | ||
| 8 | Recherche Clinique Sigma Inc. | Quebec City | Canada | ||
| 9 | Medicor Research Inc. | Sudbury | Canada | ||
| 10 | Canadian Phase Onward Inc. | Toronto | Canada |
Sponsors and Collaborators
- BUZZZ Pharmaceuticals Limited
- Veristat, Inc.
Investigators
- Study Director: Deirdre O'Keeffe, PhD, Buzzz Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-G001-P2