Osteoarthritis of KneePhase 3AMZ001NCT06693648
A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
A Phase 3 study testing AMZ001 Diclofenac gel in people with Osteoarthritis of Knee and Osteoarthritis, Knee, run by Amzell at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee, Osteoarthritis, Knee
- What is being tested?
- AMZ001 Diclofenac gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 549 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 18 Feb 2025to 13 Apr 2026
- Phase
- Phase 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
- 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 10.
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- 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.
Who cannot join
- 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.
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- 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.
- Current malignancy or treatment for malignancy within the past five years, with the exception of non-melanoma skin cancer, unless affecting the target knee area, or carcinoma in situ events.
- Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the participant's participation in the trial.
- Secondary OA of the target knee, previous procedures or trauma affecting joint homeostasis including total meniscectomy or septic arthritis, or any other serious condition leading to secondary OA of the target knee.
- Reported incidence of any of the following diseases: known OA of the hip(s) if pain in either or both hip(s) exceeds that of the target knee using the WOMAC hip pain subscore, or presence of significant radicular back pain.
- Presence of severe pain in either knee, defined as > 45 out of 50 in response to the WOMAC pain sub-score (5 questions), at the time of screening and baseline, regardless of the eligibility of the contralateral knee.
- Presence of a defined cut-off of pain variability during the screening period of 1.5 out of 10:
- Pain Numeric Rating Scale (NRS) scores must be recorded for the target knee on at least 4 out of the 7 days immediately preceding baseline (Day 1)
- Observed standard deviation of the Daily osteoarthritis (OA) knee pain diary average NRS intensity score for 7 days immediately preceding baseline (Day
- 1) must not exceed 1.5
- Body mass index > 45.0 kg/m2.
- Estimated glomerular filtration (eGFR) rate < 30 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula.
- 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.
- Use of any topical medication on the planned application site within 15 days of the time of randomization.
- Use of moderate or higher strength 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.
- Pregnant and breastfeeding women are excluded for participation.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States7 sites
Eastern Research Inc
Hialeah, Florida, 33013
Future Medical Research
Longwood, Florida, 32750
West Clinical Research
Morehead City, North Carolina, 28557
DelRicht Research
New Orleans, Louisiana, 70115
DelRicht Research
Rockville, Maryland, 20852
Millennium Clinical Trials
Thousand Oaks, California, 91360
Oakland Medical Research
Troy, Michigan, 48085
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Osteoarthritis of Knee, Osteoarthritis, Knee
- Being tested
- AMZ001 Diclofenac gel, Placebo gel
- Keywords
- AMZ001, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMZ001 Diclofenac gelDrug
Diclofenac gel applied once daily
Placebo gelDrug
Matching placebo gel applied once daily
| Study group | Role | What they receive |
|---|---|---|
| AMZ001 diclofenac gel | Experimental | Not described Receives: Drug: AMZ001 Diclofenac gel |
| Placebo gel | Placebo comparator | Not described Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the WOMAC Pain Sub-score in the Target Knee at Week 2.
Change from baseline in the WOMAC pain sub-score in the target knee at week 2. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours.
For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points.
Scale: 0-100, 100 being the worse
Measured: Baseline and Week 2
Secondary outcomes (9)
Change From Baseline in the WOMAC Pain Sub-score at Week 1, in the Target Knee
Change from baseline in the WOMAC pain sub-score in the target knee at week 1. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours.
For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points.
Scale: 0-100, 100 being the worse
Measured: Baseline and Week 1
Change From Baseline in Daily Pain at Day 8 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 8 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 8
Change From Baseline in Daily Pain at Day 7 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 7 using an 11-point Numeric Rating Scale (NRS) NRS scale: 0-10, 10 being worse
Measured: Baseline and Day 7
Change From Baseline in Daily Pain at Day 6 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 6 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 6
Change From Baseline in Daily Pain at Day 5 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 5 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 5
Change From Baseline in Daily Pain at Day 4 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 4 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 4
Change From Baseline in Daily Pain at Day 3 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 3 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 3
Change From Baseline in Daily Pain at Day 2 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 2 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 2
Change From Baseline in Daily Pain at Day 1 Using an 11-point Numeric Rating Scale (NRS)
Change from baseline in daily pain at Day 1 using an 11-point Numeric Rating Scale (NRS) NRS: Numeric Rating Scale Scale: 0 -10, 10 being the worse
Measured: Baseline and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Feb 2025
- Primary completion22 Dec 2025
- Study completion13 Apr 2026
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 of 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amzell
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693648
- Sponsor's protocol ID
- AMZ001-007
- Other IDs
- 2024-517404-11
- Acronym
- AMZ001
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2024
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06693648
- Acronym / sponsor ID
- AMZ001 / AMZ001-007
- Conditions
- Osteoarthritis of Knee, Osteoarthritis, Knee
- Keywords
- AMZ001, Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- AmzellIndustry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Posted 15 Jul 2026
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMZ001 diclofenac gel | Experimental | Drug: AMZ001 Diclofenac gel |
| Placebo gel | Placebo comparator | Drug: Placebo gel |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
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 |
|---|---|---|
| AMZ001 Diclofenac gelDiclofenac gel applied once daily | Drug | AMZ001 diclofenac gel |
| Placebo gelMatching placebo gel applied once daily | Drug | Placebo gel |
Primary outcome
Change From Baseline in the WOMAC Pain Sub-score in the Target Knee at Week 2.
Time frame: Baseline and Week 2
Change from baseline in the WOMAC pain sub-score in the target knee at week 2. WOMAC: Western Ontario and McMasters University Osteoarthritis Index Participants will answer all of the 5 questions of WOMAC pain sub-score for themselves, using an 11-box numerical rating scale (with categories of 0 to 10), with reference to the past 24 hours. For convenience and ease of interpretation, total WOMAC pain sub-score will be normalized on scales of 0 to 100 points. Scale: 0-100, 100 being the worse
9 secondary outcomes
Change From Baseline in the WOMAC Pain Sub-score at Week 1, in the Target Knee
Time frame: Baseline and Week 1
Change From Baseline in Daily Pain at Day 8 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 8
Change From Baseline in Daily Pain at Day 7 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 7
Change From Baseline in Daily Pain at Day 6 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 6
Change From Baseline in Daily Pain at Day 5 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 5
Change From Baseline in Daily Pain at Day 4 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 4
Change From Baseline in Daily Pain at Day 3 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 3
Change From Baseline in Daily Pain at Day 2 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 2
Change From Baseline in Daily Pain at Day 1 Using an 11-point Numeric Rating Scale (NRS)
Time frame: Baseline and Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMZ001 Diclofenac gel in people with Osteoarthritis of Knee and Osteoarthritis, Knee, run by Amzell at 11 sites in 5 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 10 inclusion and 27 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, China, Czechia, Denmark, Poland. 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 phase mean?
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 15 Jul 2026). 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?
Change From Baseline in the WOMAC Pain Sub-score in the Target Knee at Week 2. (time frame: Baseline and Week 2). 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 15 Jul 2026.