Phase
Condition
Osteoarthritis
Treatment
AMZ001 Diclofenac gel
Placebo gel
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is able to read and understand the language and content of the studymaterial, understand the requirements for study visits, and is willing to provideinformation at the scheduled evaluations and appropriate written informed consenthas been obtained.
Femorotibial osteoarthritis (OA) of the knee, according to the American College ofRheumatology (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-rayobtained during screening, or on a recent (within 6 months) X-ray image whichfulfils 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 ofscreening and baseline.
The WOMAC pain sub-score on the target knee must exceed the one on the contralateralknee, regardless of the eligibility of the contralateral knee.
At screening Visit 1a, participants report that their typical OA knee pain in one orboth knees when not using medication is ≥4 out of 10.
Daily OA knee pain diary average numerical rating scale (NRS) score of ≥4 and ≤9 inthe target knee, for the 7 days immediately preceding baseline (Day 1). The averagecalculation is based on the recorded scores during this entire period with arequirement of at least 4 days of data recorded.
Women of child-bearing potential must use at least an acceptably effective method ofcontraception (progestogen-only oral hormonal contraception, where inhibition ofovulation is not the primary mode of action, male or female condom with or withoutspermicide, cap, diaphragm or sponge with spermicide) from enrolment up to at least 3 months after the study end. Postmenopausal status is defined as being amenorrheicfor at least 1 year prior to screening. Sexually active men with a female partner ofchildbearing potential must agree to use condom from enrolment up to at least 3months 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 asbursitis, tendonitis, etc.) based on participant report.
Except for OA, the participant is in reasonably good health as determined by theInvestigator.
Exclusion
Exclusion Criteria:
Known or suspected hypersensitivity to or previous hypersensitivity reactions todiclofenac or of the excipients in either of the investigational products.
Patients in whom asthma, angioedema, urticaria, or acute rhinitis are precipitatedby 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 kneewithin 6 months of screening or into any other joint within 30 days of screening.
High dose (equivalent to > 10 mg of prednisone/day) systemic corticosteroidtreatment 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 toscreening or aspiration of effusion of the target knee within 12 weeks prior toenrollment.
Planned surgery of the target knee within the next 12 months.
Use of a currently unapproved investigational drug, device or biologic within 3months prior to screening.
Presence of concomitant non-osteoarthritic disease affecting either knee, such asrheumatoid arthritis, psoriasis, gout or clinically relevant pseudogout, if there isreason to believe that the disease(s) may significantly interfere with theinterpretation 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 theexception of non-melanoma skin cancer, unless affecting the target knee area, orcarcinoma in situ events.
Any other abnormal laboratory results or significant medical conditions that theInvestigator believes should preclude the participant's participation in the trial.
Secondary OA of the target knee, previous procedures or trauma affecting jointhomeostasis including total meniscectomy or septic arthritis, or any other seriouscondition leading to secondary OA of the target knee.
Reported incidence of any of the following diseases: known OA of the hip(s) if painin either or both hip(s) exceeds that of the target knee using the WOMAC hip painsubscore, or presence of significant radicular back pain.
Presence of severe pain in either knee, defined as > 45 out of 50 in response to theWOMAC 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 1.5out of 10:
Pain Numeric Rating Scale (NRS) scores must be recorded for the target knee on atleast 4 out of the 7 days immediately preceding baseline (Day 1)
Observed standard deviation of the Daily osteoarthritis (OA) knee pain diary averageNRS intensity score for 7 days immediately preceding baseline (Day
- must not exceed 1.5
Body mass index > 45.0 kg/m2.
Estimated glomerular filtration (eGFR) rate < 30 mL/min using the Chronic KidneyDisease 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, orsignificant skin disease including psoriasis, as judged by the investigator.
Use of any topical medication on the planned application site within 15 days of thetime of randomization.
Use of moderate or higher strength of opioid medication for the treatment of painwithin 6 weeks before the screening visit.
Use of duloxetine, pregabalin, or gabapentin within 4 weeks before the screeningvisit.
History of alcohol or drug abuse within the past year prior to randomization.
Pregnant and breastfeeding women are excluded for participation.
Study Design
Study Description
Connect with a study center
hong Kong Center for Clinical Research
Hong Kong,
ChinaSite Not Available
Charles University
Prague,
Czech RepublicSite Not Available
Sanos Clinic
Herlev,
DenmarkSite Not Available
Medyczne Centrum Hetmanska Piotr Leszczynski
Poznan,
PolandSite Not Available
Millennium Clinical Trials
Thousand Oaks, California 91360
United StatesActive - Recruiting
Millennium Clinical Trials
Westlake Village, California 91361
United StatesSite Not Available
Eastern Research Inc
Hialeah, Florida 33013
United StatesActive - Recruiting
Future Medical Research
Longwood, Florida 32750
United StatesActive - Recruiting
DelRicht Research
New Orleans, Louisiana 70115
United StatesActive - Recruiting
DelRicht Research
Rockville, Maryland 20852
United StatesActive - Recruiting
Oakland Medical Research
Troy, Michigan 48085
United StatesActive - Recruiting
West Clinical Research
Morehead City, North Carolina 28557
United StatesSite Not Available
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