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Completed

NCT Number: NCT05007808

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aggarwal and Associates Limited, Brampton, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • On stable analgesic therapy

At Baseline:

  • Development of a flare of pain following washout of stable analgesic (NSAID and/or acetaminophen) therapy

Exclusion criteria

  • 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
  • Anticipated use of any oral or topical NSAID (apart from the study drug) during the study
  • Known sensitivity to the study drug (or any of its ingredients), or NSAIDs, or presence of contraindications, warnings, or precautions

At Baseline:

  • Worst daily pain (within the past 24 hours) in the contralateral knee assessed as >2 on the 11-point pain NRS scale
  • Non-compliance with the daily diary requirement during the Screening period.

Treatment and study plan

G001 Topical Gel

Drug

Non-steroidal anti-inflammatory drug for topical administration

Vehicle

Drug

Vehicle Gel for topical administration

Primary outcomes

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

    Time frame: Week 4

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

Secondary outcomes

  1. Worst Daytime Pain Severity Scores (11-point Pain NRS), Based on Daily Diary Recordings

    Time frame: Week 4

    Changes from Baseline to Week 4 in Worst Daytime Pain Severity Scores on a 0-10 scale, with higher scores indicating worse outcome

  2. Worst Nighttime Pain Severity Score (11-point NRS), Based on Daily Diary Recordings

    Time frame: Week 4

    Changes from Baseline to Week 4 in Worst Nighttime Pain Severity Scores recorded on a 0-10 scale, with higher scores indicating worse outcome

  3. Percent Reduction From Baseline in Worst Daytime Pain

    Time frame: Week 4

    Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Daytime Pain at Week 4/EOT

  4. Percent Reduction From Baseline in Worst Nighttime Pain

    Time frame: Week 4

    Percentage of Patients Achieving ≥ 20%, ≥ 30%, and ≥ 50% Reduction from Baseline in Worst Nighttime Pain at Week 4/EOT

  5. Change From Baseline in WOMAC Physical Function Subscale Score at Week 4/EOT

    Time frame: Week 4

    WOMAC Physical Function Subscale (17-item, score range 0-68, with higher scores indicating worse outcome)

  6. Change From Baseline in WOMAC Total Score at Week 4/EOT

    Time frame: Week 4

    WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome)

  7. Change From Baseline in WOMAC Stiffness Subscale Score at Week 4/EOT

    Time frame: Week 4

    WOMAC Stiffness Subscale (2-item, range of scores 0-8, with higher scores indicating worse outcome)

  8. Change From Baseline in WOMAC Total and Subscale Scores at Week 2

    Time frame: Week 2

    Change from Baseline to Week 2 in:

    WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)

  9. Change From Week 4 to Week 5 in WOMAC Total and Subscale Scores

    Time frame: Week 4 to Week 5

    Change from Week 4/EOT to Week 5/Flare Visit 2 (FV2) in:

    WOMAC Osteoarthritis Index Total score (24-item, score range 0-96, with higher scores indicating worse outcome) WOMAC Pain Subscale score (5-item, score range 0-20, with higher scores indicating worse pain) WOMAC Stiffness Subscale score (2-item, score range 0-8, with higher scores indicating worse stiffness) WOMAC Physical Function Subscale score (17-item, score range 0-68, with higher scores indicating worse physical function)

  10. Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Over Time

    Time frame: Weeks 2, 4 and 5

    PGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome.

    Change from Baseline in PGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules:

    Improved - defined as either of the following:

    • For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline
    • For baseline Grade = 1: a change in grade from 1 to 0

    Worsened - defined as either of the following:

    • For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline
    • For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened

  11. Change From Baseline in Investigator Global Assessment (IGA) of Disease Activity Over Time

    Time frame: Weeks 2, 4 and 5

    IGA of Disease Activity (DA) was assessed on a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor), with higher scores indicating worse outcome.

    Change from Baseline in IGA of disease activity scores was calculated and the response was classified into 3 categories according to the following rules:

    Improved - defined as either of the following:

    • For baseline Grade ≥ 2: a reduction of ≥ 2 grades from baseline
    • For baseline Grade = 1: a change in grade from 1 to 0

    Worsened - defined as either of the following:

    • For baseline Grade ≤ 2: an increase of ≥ 2 grades from baseline
    • For baseline Grade = 3: a change in grade from 3 to 4 No Change - defined as neither Improved nor Worsened

  12. PGA of Overall Treatment Benefit (OTB)

    Time frame: Weeks 2 and 4

    PGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.

  13. IGA of Overall Treatment Benefit (OTB)

    Time frame: Weeks 2 and 4

    IGA of overall treatment benefit was completed using a 5-point Likert scale (0 = very good; 1 = good; 2 = fair; 3 = poor; and 4 = very poor) after 2 and 4 weeks of treatment, with higher scores indicating worse outcome.

  14. Rescue Medication Use

    Time frame: 5 weeks

    Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.

  15. Number of Rescue Medication Doses

    Time frame: 5 weeks

    Only acetaminophen was permitted as rescue medication (up to 500 mg per dose and 2000 mg/day to manage breakthrough pain). No rescue medication use was allowed within 12 hours before an efficacy assessment.

Other outcomes

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

    Time frame: 6 weeks

    Number and percentage of participants with adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation

  2. Frequency and Severity of Application Site AEs

    Time frame: 6 weeks

    Number and percentage of participants with application site AEs

  3. Skin Irritation Test Scores (Berger/Bowman Scoring Scale)

    Time frame: Weeks 2, 4, and 6

    The Numerical Total Score is the sum of the Dermal Response score (from 0=No evidence of irritation to 7=Strong reaction spreading beyond the application site) and the numeric equivalent of Other Effects score (from 0=Slightly glazed appearance to 3=Small petechial erosions and/or scabs).

    The Numerical Total Score range is from 0 to 10, with higher scores indicating worse outcome/skin irritation.

  4. ECG Abnormalities in QT, QTc, QRS, or PR Intervals

    Time frame: 4 weeks

    Number and percentage of participants with clinically significant (CS) abnormal results in QT, QTc, QRS, or PR intervals at Week 4/EOT

  5. Changes From Baseline in Safety Laboratory Test Results

    Time frame: 6 weeks

    Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges

  6. Changes in Vital Signs Measurements

    Time frame: 6 weeks

    Mean changes (descriptive) from baseline

  7. Changes in Physical Examination

    Time frame: 6 weeks

    Number and percentage of participants with clinically significant abnormal findings

Sponsors and collaborators

Lead sponsor

BUZZZ Pharmaceuticals Limited

Industry

Collaborators

  • Veristat, Inc.

Registry information

Official study title

Phase 2 Multicenter, Double-blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy, Safety, and Local Tolerability of G001 in Patients With Osteoarthritis (OA) of the Knee

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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