AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

NCT03691844 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AMZ001-006
• Study Type: interventional
• Target: 444
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

AMZ001

Outcome Measures

Primary Outcomes (1)

• WOMAC Pain Sub-score

  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.

  baseline, week 4

Secondary Outcomes (15)

• WOMAC Total Score and WOMAC Function and Stiffness

  baseline, week 4

• WOMAC Pain Weight-bearing Score and Non-weight-bearing Score

  baseline, week 4

• ICOAP Scores

  baseline, week 4

• Physical Function

  baseline, week 4

• Proportion of Responders as Per OMERACT-OARSI Criteria

  week 4

Other Outcomes (2)

• Safety Endpoint (Adverse Events)

  weeks 1 through 4

• Skin Tolerability Assessment (Skin Reactions)

  week 4

Study Arms (4)

AMZ001 + Placebo

EXPERIMENTAL

on the target knee

Drug: AMZ001

AMZ001

EXPERIMENTAL

on the target knee

Drug: AMZ001

Placebo

PLACEBO COMPARATOR

on the target knee

Drug: Placebo

Comparator

ACTIVE COMPARATOR

Diclofenac gel on the target knee

Drug: Comparator

Interventions

AMZ001 DRUG

diclofenac gel

AMZ001; AMZ001 + Placebo

Placebo DRUG

Placebo

Placebo

Comparator DRUG

diclofenac gel

Also known as: active comparator

Comparator

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Body Mass Index \> 45.0 kg/m2.
• Generalized skin irritation, previous skin reactions upon use of topical NSAIDs, current skin irritation or redness at the planned site of gel application, or significant skin disease including psoriasis, as judged by the investigator.
• Known presence of a ulcer or any gastrointestinal bleeding within 6 months prior to screening.
• Use of moderate or higher doses of opioid medication for the treatment of pain within 6 weeks before the screening visit.
• Use of duloxetine, pregabalin, or gabapentin within 4 weeks before the screening visit.

Sponsors & Collaborators

• Amzell: lead

Study Sites (7)

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Premier Medical Associates

The Villages, Florida, 32162, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

CCR Brno, s.r.o

Brno, Czechia

Location

CCR Czech, a.s

Pardubice, Czechia

Location

CCR Prague s.r.o.

Prague, Czechia

Location

Sanos Clinic

Herlev, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Amzell B.V.

amzell-disclosure@amzell.com

+41614864000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 3 treatment arms will be double-blind, the 4th (comparator) will be single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: placebo-controlled, double-blind, randomized, parallel study

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 2, 2018
• Study Start: October 4, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: October 6, 2020
• Results First Posted: October 6, 2020

Record last verified: 2020-09

Locations

DK (1); US (3); CZ (3)