A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Once Daily Diclofenac Gel AMZ001 in the Treatment of Pain and Symptoms of Knee Osteoarthritis

Amzell11 sites in 5 countries540 target enrollmentFebruary 18, 2025

ConditionsOsteoarthritis of Knee Osteoarthritis, Knee

InterventionsAMZ001 Diclofenac gel Placebo gel

DrugsAMZ001 Diclofenac gel Placebo gel

Overview

Phase: Phase 3
Intervention: AMZ001 Diclofenac gel
Conditions: Osteoarthritis of Knee
Sponsor: Amzell
Enrollment: 540
Locations: 11
Primary Endpoint: Change from baseline in the WOMAC pain sub-score in the target knee at week 2.
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 6-week trial of a formulation of AMZ001 once daily versus placebo once daily. Participants will be evaluated for osteoarthritis by X-ray images of the knees and one knee will be selected for treatment as the target knee. The study gel will be applied directly to that knee throughout the 6 weeks of the study.

Registry

clinicaltrials.gov

Start Date

February 18, 2025

End Date

April 1, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amzell

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is able to read and understand the language and content of the study material, understand the requirements for study visits, and is willing to provide information at the scheduled evaluations and appropriate written informed consent has been obtained.
•Femorotibial osteoarthritis (OA) of the knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria (Altman et al. 1986)
•Radiological OA grade 2, or 3 of the target knee, using the Kellgren-Lawrence method (Kellgren \& Lawrence 1957) as graded by central, independent reading of X-ray obtained during screening, or on a recent (within 6 months) X-ray image which fulfils the specifications for central reading.
•Pain score rated on an 11-point numerical rating scale of the target knee of ≥20 and ≤45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline.
•The WOMAC pain sub-score on the target knee must exceed the one on the contralateral knee, regardless of the eligibility of the contralateral knee.
•At screening Visit 1a, participants report that their typical OA knee pain in one or both knees when not using medication is ≥4 out of
•Daily OA knee pain diary average numerical rating scale (NRS) score of ≥4 and ≤9 in the target knee, for the 7 days immediately preceding baseline (Day 1). The average calculation is based on the recorded scores during this entire period with a requirement of at least 4 days of data recorded.
•Women of child-bearing potential must use at least an acceptably effective method of contraception (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) from enrolment up to at least 3 months after the study end. Postmenopausal status is defined as being amenorrheic for at least 1 year prior to screening. Sexually active men with a female partner of childbearing potential must agree to use condom from enrolment up to at least 3 months after the study end.
•Knee pain in the target knee for at least 14 days of the preceding month (periarticular knee pain due to OA and not due to non-OA conditions such as bursitis, tendonitis, etc.) based on participant report.
•Except for OA, the participant is in reasonably good health as determined by the Investigator.

Exclusion Criteria

•Known or suspected hypersensitivity to or previous hypersensitivity reactions to diclofenac or of the excipients in either of the investigational products.
•Patients in whom asthma, angioedema, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
•Any physical impediment to gel application on the target knee.
•Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of screening or into any other joint within 30 days of screening.
•High dose (equivalent to \> 10 mg of prednisone/day) systemic corticosteroid treatment of more than 14 days during the past 6 months prior to screening.
•Major surgery/ arthroscopy of the target knee within the previous year prior to screening or aspiration of effusion of the target knee within 12 weeks prior to enrollment.
•Planned surgery of the target knee within the next 12 months.
•Use of a currently unapproved investigational drug, device or biologic within 3 months prior to screening.
•Presence of concomitant non-osteoarthritic disease affecting either knee, such as rheumatoid arthritis, psoriasis, gout or clinically relevant pseudogout, if there is reason to believe that the disease(s) may significantly interfere with the interpretation of the clinical response to the study drug.
•Perioperative period in the setting of coronary artery bypass graft surgery.

Arms & Interventions

AMZ001 diclofenac gel

Intervention: AMZ001 Diclofenac gel

Placebo gel

Intervention: Placebo gel

Outcomes

Primary Outcomes

Change from baseline in the WOMAC pain sub-score in the target knee at week 2.

Time Frame: Baseline and Week 2

WOMAC: Western Ontario and McMasters University Osteoarthritis Index Scale: 0-100, 100 being the worse

Secondary Outcomes

Change from baseline in the WOMAC pain sub-score at week 1, in the target knee(Baseline and Week 1)
Change from baseline in daily pain at Day 8 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 8)
Change from baseline in daily pain at Day 7 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 7)
Change from baseline in daily pain at Day 6 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 6)
Change from baseline in daily pain at Day 5 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 5)
Change from baseline in daily pain at Day 4 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 4)
Change from baseline in daily pain at Day 3 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 3)
Change from baseline in daily pain at Day 2 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 2)
Change from baseline in daily pain at Day 1 using an 11-point Numeric Rating Scale (NRS)(Baseline and Day 1)