Clinical Trials/NCT03691844

NCT03691844

Completed

Phase 2

A Placebo-controlled, Double-blind, Randomized, Trial of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

Amzell7 sites in 3 countries444 target enrollmentOctober 4, 2018

ConditionsOsteoarthritis, Knee

InterventionsAMZ001 Placebo Comparator

DrugsAMZ001 Placebo Comparator

Overview

Phase: Phase 2
Intervention: AMZ001
Conditions: Osteoarthritis, Knee
Sponsor: Amzell
Enrollment: 444
Locations: 7
Primary Endpoint: WOMAC Pain Sub-score
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with a commercial gel four times 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 4 weeks of the study.

Registry

clinicaltrials.gov

Start Date

October 4, 2018

End Date

July 9, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amzell

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Osteoarthritis of the knee, according the American College of Rheumatology (ACR) clinical and X-ray criteria.
•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, after washout of any pain relief medication.
•Women of child-bearing potential must use at least an acceptably effective method of contraception from enrollment up to at least 3 months after the study end.
•Knee pain in the target knee for 14 days of the preceding month (knee pain due to osteoarthritis and not due to another condition such as bursitis, tendinitis, etc.) based on subject report.
•On stable pain therapy (i.e., at least 3 days per week for the previous month) with an oral or topical NSAID prescribed by physician for 30 days prior to the Screening Visit and/or prescribed over-the-counter.
•Except for osteoarthritis, in reasonably good health as determined by the Investigator.

Exclusion Criteria

•Known or suspected hypersensitivity to diclofenac, other non-steroidal anti-inflammatory drugs or related substances including aspirin, any of the components in either of the investigation products, or any physical impediment to gel application on the target knee.
•Injection 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 oral/injected corticosteroid treatment of more than 14 days during the past 6 months prior to screening.
•Major surgery or arthroscopy of the target knee within the previous year prior to screening.
•Planned surgery of the target knee within the next 3 months.
•Presence of an additional non-osteoarthritic disease affecting either knee, such as rheumatoid arthritis, psoriasis, gout or pseudo-gout, if there is reason to believe that the disease(s) may significantly interfere with the interpretation of the clinical response to the study drug.
•Medical history of coronary artery bypass graft surgery.
•Current cancer or treatment for cancer within the past five years, with the exception of non-melanoma skin cancer, unless affecting the target knee area.
•Secondary osteoarthritis of the target knee, previous procedures or trauma affecting joint of the target knee.
•Reported incidence of any of the following diseases: known osteoarthritis of the hip(s) if pain in hip(s) exceeds that of the target knee using the WOMAC Hip Pain subscore, presence of significant back pain, or at least one migraine attack within the past 12 months before screening, as reported by the subject.

Arms & Interventions

AMZ001 + Placebo

on the target knee

Intervention: AMZ001

AMZ001

on the target knee

Intervention: AMZ001

Placebo

on the target knee

Intervention: Placebo

Comparator

Diclofenac gel on the target knee

Intervention: Comparator

Outcomes

Primary Outcomes

WOMAC Pain Sub-score

Time Frame: baseline, week 4

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 \[no pain\]-50 \[extreme pain\]) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.

Secondary Outcomes

WOMAC Total Score and WOMAC Function and Stiffness(baseline, week 4)
WOMAC Pain Sub-score (Dose Comparison)(baseline, week 4)
Impact of Osteoarthritis on Daily Living (PGA Score)(baseline, week 4)
ICOAP Scores(baseline, week 4)
Physical Function(baseline, week 4)
WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison)(baseline, week 4)
Proportion of Responders as Per OMERACT-OARSI Criteria(week 4)
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison)(baseline, week 4)
Physical Function (Dose Comparison)(baseline, week 4)
Work Productivity(baseline, week 4)
Total Dose of Rescue Medication(weeks 1 through 4)
Time Between Baseline and First Use of Rescue Medication(weeks 1 through 4)
ICOAP Scores (Dose Comparison)(baseline, week 4)
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score(baseline, week 4)
Change in Quality of Life: EQ5D VAS Score(baseline, week 4)