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Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee

Phase 2
Waitlist Available
Research Sponsored by BUZZZ Pharmaceuticals Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4, and 6

Summary

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.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 4, and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT
Secondary study objectives
Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time
Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT
+12 more
Other study objectives
Changes From Baseline in Safety Laboratory Test Results
Changes in Physical Examination
Changes in Vital Signs Measurements
+4 more

Side effects data

From 2023 Phase 2 trial • 210 Patients • NCT05007808
10%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
G001 Topical Gel
Vehicle Topical Gel

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G001 Topical Gel
2021
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

BUZZZ Pharmaceuticals LimitedLead Sponsor
Veristat, Inc.OTHER
11 Previous Clinical Trials
2,080 Total Patients Enrolled
1 Trials studying Osteoarthritis
381 Patients Enrolled for Osteoarthritis
Deirdre O'Keeffe, PhDStudy DirectorBuzzz Pharma
~43 spots leftby Dec 2025
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