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G001 Topical Gel for Osteoarthritis

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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4, and 6
Awards & highlights

Study Summary

This trial is a study to compare the efficacy, safety, and local tolerability of G001 topical gel to a matching Vehicle topical gel in patients with symptomatic OA of the knee.

Eligible Conditions
  • Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in WOMAC Pain Subscale Score
Secondary outcome measures
Change from Baseline in Investigator Global Assessment (IGA) of disease activity over time
Disease
Change from Baseline in WOMAC Physical Function Subscale score
+8 more
Other outcome measures
Changes from baseline in safety laboratory test results
Changes in physical examination
Changes in vital signs measurements
+7 more

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
2021. "Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05007808.
~49 spots leftby Apr 2025
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