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

NCT05007808 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2020-G001-P2
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 10

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; knee; topical therapy; pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in WOMAC Pain Subscale Score at Week 4/EOT

  Changes from Baseline in WOMAC Pain Subscale Score (5-item scale, score range 0-20, with higher scores indicating worse outcome)

  Week 4

Secondary Outcomes (15)

• 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

Other Outcomes (7)

• Number of Participants With AEs, Study Drug-related AEs, Serious AEs, and AEs Leading to Study Drug Discontinuation

  6 weeks

• Frequency and Severity of Application Site AEs

  6 weeks

• Skin Irritation Test Scores (Berger/Bowman Scoring Scale)

  Weeks 2, 4, and 6

Study Arms (2)

G001 Topical Gel

EXPERIMENTAL

G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.

Drug: G001 Topical Gel

Vehicle Topical Gel

PLACEBO COMPARATOR

Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.

Drug: Vehicle

Interventions

G001 Topical Gel DRUG

Non-steroidal anti-inflammatory drug for topical administration

G001 Topical Gel

Vehicle DRUG

Vehicle Gel for topical administration

Vehicle Topical Gel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Received intra-articular viscosupplementation/hyaluronate, joint lavage, or other invasive therapies to the index knee in the past 90 days
• Treatment with or need for any of the following: (1) oral or intramuscular corticosteroids within the past 90 days; (2) intra-articular corticosteroid injection into the index knee within the past 90 days, or into any other joint within the past 30 days; (3) current use of topical corticosteroids on the index knee
• Prior stable therapy with an opioid analgesic, or anticipated need for opioid analgesic use during the study
• Use of sedative hypnotic medication, antidepressants with known analgesic effect, antipsychotics, antiepileptics, and anti-Parkinson drugs within the past 14 days
• Regular use of medication for headaches

Sponsors & Collaborators

• BUZZZ Pharmaceuticals Limited: lead
• Veristat, Inc.: collaborator

Study Sites (10)

Aggarwal and Associates Limited

Brampton, Canada

Location

Medicor Research Inc.

Greater Sudbury, Canada

Location

Manna Research

Lévis, Canada

Location

Recherche GCP Research

Montreal, Canada

Location

Alpha recherche Clinique (1)

Québec, Canada

Location

Alpha Recherche Clinique (2)

Québec, Canada

Location

Centre de Recherche Saint-Louis

Québec, Canada

Location

G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc.

Québec, Canada

Location

Recherche Clinique Sigma Inc.

Québec, Canada

Location

Canadian Phase Onward Inc.

Toronto, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Deirdre O'Keefe, PhD, Head of IP and Portfolio Management
• Organization: Buzzz Pharmaceuticals Limited

deirdre@hotmail.co.uk

+447733104786

Study Officials

• Deirdre O'Keeffe, PhD

  Buzzz Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 16, 2021
• Study Start: January 6, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 10, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)