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
Overview
- Phase
- Phase 2
- Intervention
- G001 Topical Gel
- Conditions
- Osteoarthritis, Knee
- Sponsor
- BUZZZ Pharmaceuticals Limited
- Enrollment
- 210
- Locations
- 10
- Primary Endpoint
- Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
G001 Topical Gel
G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Intervention: G001 Topical Gel
Vehicle Topical Gel
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Intervention: Vehicle
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings(Week 4)
- Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings(Week 4)
- Percent Reduction From Baseline in Worst Daytime Pain(Week 4)
- Percent Reduction From Baseline in Worst Nighttime Pain(Week 4)
- Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT(Week 4)
- Change From Baseline in WOMAC Total Score at Week 4/EOT(Week 4)
- Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT(Week 4)
- Change From Baseline in WOMAC Total and Subscale Scores at Week 2(Week 2)
- Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores(Week 4 to Week 5)
- Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time(Weeks 2, 4 and 5)
- Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time(Weeks 2, 4 and 5)
- PGA of Overall Treatment Benefit (OTB)(Weeks 2 and 4)
- IGA of Overall Treatment Benefit (OTB)(Weeks 2 and 4)
- Rescue Medication Use(5 weeks)
- Number of Rescue Medication Doses(5 weeks)