Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Recruiting at 9 trial locations
HM
Overseen ByHeather M Karabaich
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: BUZZZ Pharmaceuticals Limited
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
This trial tests a special gel applied to the skin for patients with knee osteoarthritis pain. The gel aims to reduce pain and inflammation when used on the knee.
Research Team
DO
Deirdre O'Keeffe, PhD
Principal Investigator
Buzzz Pharma
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
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants receive G001 or Vehicle topical gel applied to the index knee four times a day
4 weeks
3 visits (in-person) at Weeks 2, 4, and 5
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
1 visit (in-person) for end-of-study evaluations
Treatment Details
Interventions
- G001 Topical Gel
- Vehicle
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: G001 Topical GelExperimental Treatment1 Intervention
G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Group II: Vehicle Topical GelPlacebo Group1 Intervention
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BUZZZ Pharmaceuticals Limited
Lead Sponsor
Trials
1
Recruited
210+
Veristat, Inc.
Collaborator
Trials
12
Recruited
2,300+
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