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

NCT05007808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-04-23

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

G001 Topical Gel

Non-steroidal anti-inflammatory drug for topical administration

DRUG

Vehicle

Vehicle Gel for topical administration

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • BUZZZ Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Deirdre O'Keeffe, PhD · Buzzz Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2023-01-04
Completion
2023-01-10
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007808 on ClinicalTrials.gov