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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
G001 Topical Gel
Vehicle
Sponsored by
BUZZZ Pharmaceuticals Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, topical therapy, pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aggarwal and Associates Limited
  • Manna Research
  • Recherche GCP Research
  • Alpha recherche Clinique (1)
  • Alpha Recherche Clinique (2)
  • Centre de Recherche Saint-Louis
  • G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc.
  • Recherche Clinique Sigma Inc.
  • Medicor Research Inc.
  • Canadian Phase Onward Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G001 Topical Gel

Vehicle Topical Gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline in WOMAC Pain Subscale Score
0-20 scale, with higher scores indicating worse outcome

Secondary Outcome Measures

Change from Baseline in WOMAC Physical Function Subscale score
0-68 scale, with higher scores indicating worse outcome
Change from Baseline in WOMAC Total score
0-96 scale, with higher scores indicating worse outcome
Change from Baseline in WOMAC Stiffness Subscale score
0-8 scale, with higher scores indicating worse outcome
Change from Baseline in WOMAC Total and Subscale Scores
Change from Week 4 to Week 5 in WOMAC Total and Subscale Scores
Worst daily and nightly pain severity scores (11-point pain NRS) from patient diary
0-10 scale, with higher scores indicating worse outcome
Change from Baseline in Patient Global Assessment (PGA) of disease activity over time
0-4 scale, with higher scores indicating worse outcome
Change from Baseline in Investigator Global Assessment (IGA) of disease activity over time
0-4 scale, with higher scores indicating worse outcome
PGA of overall treatment benefit
0-4 scale, with higher scores indicating worse outcome
IGA of overall treatment benefit
0-4 scale, with higher scores indicating worse outcome
Rescue medication use

Full Information

First Posted
July 22, 2021
Last Updated
April 13, 2023
Sponsor
BUZZZ Pharmaceuticals Limited
Collaborators
Veristat, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05007808
Brief Title
Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BUZZZ Pharmaceuticals Limited
Collaborators
Veristat, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, knee, topical therapy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G001 Topical Gel
Arm Type
Experimental
Arm Description
G001 Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Arm Title
Vehicle Topical Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Gel, 4 grams applied to the index knee four times a day over 4 weeks.
Intervention Type
Drug
Intervention Name(s)
G001 Topical Gel
Intervention Description
Non-steroidal anti-inflammatory drug for topical administration
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle Gel for topical administration
Primary Outcome Measure Information:
Title
Change from Baseline in WOMAC Pain Subscale Score
Description
0-20 scale, with higher scores indicating worse outcome
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change from Baseline in WOMAC Physical Function Subscale score
Description
0-68 scale, with higher scores indicating worse outcome
Time Frame
Week 4
Title
Change from Baseline in WOMAC Total score
Description
0-96 scale, with higher scores indicating worse outcome
Time Frame
Week 4
Title
Change from Baseline in WOMAC Stiffness Subscale score
Description
0-8 scale, with higher scores indicating worse outcome
Time Frame
Week 4
Title
Change from Baseline in WOMAC Total and Subscale Scores
Time Frame
Week 2
Title
Change from Week 4 to Week 5 in WOMAC Total and Subscale Scores
Time Frame
Week 4 to Week 5
Title
Worst daily and nightly pain severity scores (11-point pain NRS) from patient diary
Description
0-10 scale, with higher scores indicating worse outcome
Time Frame
Weeks 4 and 5
Title
Change from Baseline in Patient Global Assessment (PGA) of disease activity over time
Description
0-4 scale, with higher scores indicating worse outcome
Time Frame
Weeks 2, 4 and 5
Title
Change from Baseline in Investigator Global Assessment (IGA) of disease activity over time
Description
0-4 scale, with higher scores indicating worse outcome
Time Frame
Weeks 2, 4 and 5
Title
PGA of overall treatment benefit
Description
0-4 scale, with higher scores indicating worse outcome
Time Frame
Weeks 2 and 4
Title
IGA of overall treatment benefit
Description
0-4 scale, with higher scores indicating worse outcome
Time Frame
Weeks 2 and 4
Title
Rescue medication use
Time Frame
5 weeks
Other Pre-specified Outcome Measures:
Title
Frequency and severity of adverse events (AEs), study drug-related AEs, serious AEs, and AEs leading to study drug discontinuation
Description
Number and percentage of participants with AEs
Time Frame
6 weeks
Title
Frequency and severity of application site AEs
Description
Number and percentage of participants with application site AEs
Time Frame
5 weeks
Title
Skin irritation test scores
Description
0-10 scale, with higher scores indicating worse outcome
Time Frame
Weeks 2, 4, and 6
Title
Changes from baseline in safety laboratory test results
Description
Mean changes (descriptive) and shifts from normal baseline to laboratory values outside reference ranges
Time Frame
6 weeks
Title
Changes in vital signs measurements
Description
Mean changes (descriptive) from baseline
Time Frame
6 weeks
Title
Changes in physical examination
Description
Number and percentage of participants with clinically significant abnormal findings
Time Frame
6 weeks
Title
ECG QT interval
Description
Number and percentage of participants with clinically significant abnormal results
Time Frame
4 weeks
Title
ECG QTc interval
Description
Number and percentage of participants with clinically significant abnormal results
Time Frame
4 weeks
Title
ECG QRS interval
Description
Number and percentage of participants with clinically significant abnormal results
Time Frame
4 weeks
Title
ECG PR interval
Description
Number and percentage of participants with clinically significant abnormal results
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre O'Keeffe, PhD
Organizational Affiliation
Buzzz Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Aggarwal and Associates Limited
City
Brampton
Country
Canada
Facility Name
Manna Research
City
Lévis
Country
Canada
Facility Name
Recherche GCP Research
City
Montréal
Country
Canada
Facility Name
Alpha recherche Clinique (1)
City
Quebec City
Country
Canada
Facility Name
Alpha Recherche Clinique (2)
City
Quebec City
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec City
Country
Canada
Facility Name
G.R.M.O. (Groupe de Recherche en Maladie Osseuses) Inc.
City
Quebec City
Country
Canada
Facility Name
Recherche Clinique Sigma Inc.
City
Quebec City
Country
Canada
Facility Name
Medicor Research Inc.
City
Sudbury
Country
Canada
Facility Name
Canadian Phase Onward Inc.
City
Toronto
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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