Diclofenac Gel AMZ001 3.06% for the Treatment of Knee Osteoarthritis Symptoms
Sponsor:
Amzell
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 18, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | October 2018 | ||
| Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
WOMAC pain sub-score[ Time Frame: week 4 ] Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain sub-score (questions 1-5; score 0 [no pain]-20 [extreme pain]) on target knee (double-blind treatment group only) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Diclofenac Gel AMZ001 3.06% for the Treatment of Knee Osteoarthritis Symptoms |
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| Official Title ICMJE | A Placebo-controlled, Double-blind, Randomized, Trial of Diclofenac Gel AMZ001 3.06% for the Treatment of Knee Osteoarthritis Symptoms |
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| Brief Summary | This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a novel formulation of diclofenac gel AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with commercial diclofenac 1% (Voltaren) gel four times daily. |
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| Detailed Description | This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week trial of a novel formulation of diclofenac gel AMZ001 once or twice daily versus placebo twice daily, including a single-blind treatment group with commercial diclofenac 1% (Voltaren) gel four times daily. Subjects 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 Type ICMJE | Interventional | ||
| Study Phase | Phase 2/Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: placebo-controlled, double-blind, randomized, parallel study Masking: Interventional Masking Description:3 treatment arms will be double-blind, the 4th (Voltaren) will be single-blind Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
440 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 2019 | ||
| Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Subject 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. 2. Femorotibial osteoarthritis of the knee, according the American College of Rheumatology (ACR) clinical and radiographic criteria. 3. Radiological OA grade 1, 2, or 3 of the target knee, using the Kellgren-Lawrence method as graded by central, independent reading of X-ray obtained during screening, or on a recent (within 6 months) X-ray image which fulfills the specifications for central reading. 4. 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. The subject should have undergone a washout-period of at least 5 half-lives of any analgesic medication before completing the screening questionnaire. 5. Women of child-bearing potential must use at least an acceptably effective method of contraception (progesterone-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). 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 enrollment up to at least 3 months after the study end. 6. Knee pain in the target knee for 14 days of the preceding month (periarticular knee pain due to OA and not due to non-OA conditions such as bursitis, tendinitis, etc.) based on subject report. 7. 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 (OTC). 8. Except for osteoarthritis, the subject is in reasonably good health as determined by the Investigator. Exclusion Criteria: 1. Known or suspected hypersensitivity to or previous hypersensitivity reactions to diclofenac, other non-steroidal anti-inflammatory drugs or related substances including aspirin, any of the excipients in either of the investigation products, or any physical impediment to gel application on the target knee. 2. 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. 3. High dose (equivalent to > 5 mg of prednisone/day) systemic corticosteroid treatment of more than 14 days during the past 6 months prior to screening. 4. Major surgery or arthroscopy of the target knee within the previous year prior to screening. 5. Planned surgery of the target knee within the next 3 months. 6. Use of a currently unapproved investigational drug, device or biologic within 6 months prior to screening. 7. Presence of concomitant 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. 8. Medical history of coronary artery bypass graft surgery. 9. 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. 10. Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the subject's participation in the trial. 11. Secondary osteoarthritis 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. 12. 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 radicular back pain, or at least one migraine attack within the past 12 months before screening, as reported by the subject. 13. Body Mass Index > 45.0 kg/m2. 14. Estimated creatinine clearance < 30 mL/min using the Modification of Diet in Renal Disease (MDRD) method. 15. 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. 16. Known presence of gastroduodenal ulcer or any gastrointestinal bleeding (except hemorrhoidal) within 6 months prior to screening. 17. Use of any topical medication on the planned application site within 30 days before the screening visit. 18. Use of moderate or higher doses of opioid medication for the treatment of pain within 6 weeks before the screening visit. 19. Use of duloxetine, pregabalin, or gabapentin within 4 weeks before the screening visit. 20. History of alcohol or drug abuse within the past year prior to randomization. | ||
| Sex/Gender |
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| Ages | 40 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Czechia|Denmark|United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Amzell | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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