Osteoarthritis, KneePhase 2/3NCT03691844
AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
A Phase 2/3 study testing AMZ001 and Comparator in people with Osteoarthritis, Knee, run by Amzell at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- AMZ001 and Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 4 Oct 2018to 9 Jul 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of alcohol or drug abuse within the past year prior to randomization.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
Clinical Research Consulting
Milford, Connecticut, 06460
Premier Medical Associates
The Villages, Florida, 32162
Upstate Clinical Research Associates
Williamsville, New York, 14221
Czechia3 sites
CCR Brno, s.r.o
Brno
CCR Czech, a.s
Pardubice
CCR Prague s.r.o.
Prague
About this study
Official title: A Placebo-controlled, Double-blind, Randomized, Trial of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- AMZ001, Placebo, Comparator
- Keywords
- AMZ001
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMZ001Drug
diclofenac gel
PlaceboDrug
Placebo
ComparatorDrug
Also called active comparator
diclofenac gel
| Study group | Role | What they receive |
|---|---|---|
| AMZ001 + Placebo | Experimental | on the target knee Receives: Drug: AMZ001 |
| AMZ001 | Experimental | on the target knee Receives: Drug: AMZ001 |
| Placebo | Placebo comparator | on the target knee Receives: Drug: Placebo |
| Comparator | Active comparator | Diclofenac gel on the target knee Receives: Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, week 4
Secondary outcomes (15)
WOMAC Total Score and WOMAC Function and Stiffness
Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) total score and WOMAC function (degree of difficulty experienced in performing daily activities - 17 questions score 0-170) and stiffness (the degree and timing of joint stiffness - 2 questions score 0-20). The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Measured: baseline, week 4
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score
Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) pain weight-bearing score (questions 1,2, \& 5; score 0-30) and non-weight-bearing score (questions 3\&4; score 0-20) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Measured: baseline, week 4
ICOAP Scores
Change from baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) scores (score 0 [no pain]- 4 [extreme pain]). ICOAP scores were normalized to a 0-100 point scale, where 0 is no pain and higher scores indicate greater pain.
Measured: baseline, week 4
Physical Function
Change in baseline in physical function assessed by the chair-stand test. The test measures the maximum number of chair stand repetitions possible in a 30-second period with out using the arms. Where 0 is no repetition completed and higher numbers corresponds to greater repetitions and physical function.
Measured: baseline, week 4
Proportion of Responders as Per OMERACT-OARSI Criteria
Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI) response involves changes that are deemed to be clinically relevant in three domains: pain, function, and PGA (Patient Global Assessment). For each of these domains, ranges are defined for absolute and percent changes from baseline that correspond to "high improvement" and "moderate improvement". OMERACT-OARSI response is defined as either high improvement in at least 1 of WOMAC pain and function scores OR moderate improvement in at least 2 of WOMAC pain scores, WOMAC function score or Patient Global Assessment (PGA)
Measured: week 4
Total Dose of Rescue Medication
Total dose of rescue medication calculated as the average gram use/day, based on pill counts.
Measured: weeks 1 through 4
Time Between Baseline and First Use of Rescue Medication
Time between baseline and first use of rescue medication.
Measured: weeks 1 through 4
WOMAC Pain Sub-score (Dose Comparison)
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 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Measured: baseline, week 4
ICOAP Scores (Dose Comparison)
Change from baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) scores (score 0 [no pain]- 4 [extreme pain]). ICOAP scores were normalized to a 0-100 point scale, where 0 is no pain and higher scores indicate greater pain.
Measured: baseline, week 4
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison)
Changes from baseline in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain weight-bearing score (questions 1,2, \& 5; score 0-30) and non-weight-bearing score (questions 3\&4; score 0-20) on target knee. The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Measured: baseline, week 4
Physical Function (Dose Comparison)
Change in baseline assessed by the chair-stand test. The test measures the maximum number of chair stand repetitions possible in a 30-second period with out using the arms. Where 0 is no repetition completed and higher numbers corresponds to greater repetitions and physical function.
Measured: baseline, week 4
WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison)
Change from baseline in Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) total score and WOMAC function (degree of difficulty experienced in performing daily activities - 17 questions score 0-170) and stiffness (the degree and timing of joint stiffness - 2 questions score 0-20). The WOMAC scores were normalized to a 0-100 point scale for data analysis, where 0 is no pain and higher scores indicate greater pain, stiffness or difficulty in performing daily tasks.
Measured: baseline, week 4
Impact of Osteoarthritis on Daily Living (PGA Score)
Change from baseline in Impact of OA daily living assessed using Patient Global Assessment (PGA) score. PGA is scored on a 11-point scale from 0 (none) to 10 (extreme), where higher scores represents a higher level of disease activity or worse health.
Measured: baseline, week 4
Work Productivity
Change from baseline in work productivity and activity assessed by the Work Productivity and Active Impairment (WPAI scores 0-100% in four different categories: absenteeism, presenteeism, work productivity loss, and activity impairment). Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Measured: baseline, week 4
Change in Quality of Life: EQ5D VAS Score
The EuroQol-5 Domain (EQ-5D) is a standardized generic measure of health-related quality of life. The visual analog scale (VAS) is scored on a 0-100 scale, where 0 is "the worst health you can imagine" and 100, "the best health you can imagine".
Measured: baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start4 Oct 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled, double-blind, randomized, parallel study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amzell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691844
- Sponsor's protocol ID
- AMZ001-006
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2018
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Randomized, Trial of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
- ClinicalTrials.gov ID
- NCT03691844
- Acronym / sponsor ID
- AMZ001-006
- Conditions
- Osteoarthritis, Knee
- Keywords
- AMZ001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- AmzellIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 6 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- placebo-controlled, double-blind, randomized, parallel study
| Arm | Type | Receives |
|---|---|---|
| AMZ001 + Placebo | Experimental | Drug: AMZ001on the target knee |
| AMZ001 | Experimental | Drug: AMZ001on the target knee |
| Placebo | Placebo comparator | Drug: Placeboon the target knee |
| Comparator | Active comparator | Drug: ComparatorDiclofenac gel on the target knee |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMZ001diclofenac gel | Drug | AMZ001, AMZ001 + Placebo |
| PlaceboPlacebo | Drug | Placebo |
| ComparatorAlso: active comparatordiclofenac gel | Drug | Comparator |
Primary outcome
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.
15 secondary outcomes
WOMAC Total Score and WOMAC Function and Stiffness
Time frame: baseline, week 4
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score
Time frame: baseline, week 4
ICOAP Scores
Time frame: baseline, week 4
Physical Function
Time frame: baseline, week 4
Proportion of Responders as Per OMERACT-OARSI Criteria
Time frame: week 4
Total Dose of Rescue Medication
Time frame: weeks 1 through 4
Time Between Baseline and First Use of Rescue Medication
Time frame: weeks 1 through 4
WOMAC Pain Sub-score (Dose Comparison)
Time frame: baseline, week 4
ICOAP Scores (Dose Comparison)
Time frame: baseline, week 4
WOMAC Pain Weight-bearing Score and Non-weight-bearing Score (Dose Comparison)
Time frame: baseline, week 4
Physical Function (Dose Comparison)
Time frame: baseline, week 4
WOMAC Total Score and WOMAC Function and Stiffness (Dose Comparison)
Time frame: baseline, week 4
Impact of Osteoarthritis on Daily Living (PGA Score)
Time frame: baseline, week 4
Work Productivity
Time frame: baseline, week 4
Change in Quality of Life: EQ5D VAS Score
Time frame: baseline, week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AMZ001 and Comparator in people with Osteoarthritis, Knee, run by Amzell at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Czechia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Sub-score (time frame: baseline, week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.