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AMZ001 for the Treatment of Knee Osteoarthritis Symptoms

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ClinicalTrials.gov Identifier: NCT03691844
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amzell

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: AMZ001 Drug: Placebo Drug: Comparator Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled, double-blind, randomized, parallel study
Masking: Double (Participant, Investigator)
Masking Description: 3 treatment arms will be double-blind, the 4th (comparator) will be single-blind
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomized, Trial of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: AMZ001 + Placebo
on the target knee
Drug: AMZ001
diclofenac gel

Experimental: AMZ001
on the target knee
Drug: AMZ001
diclofenac gel

Placebo Comparator: Placebo
on the target knee
Drug: Placebo
Placebo

Active Comparator: Comparator
Diclofenac gel on the target knee
Drug: Comparator
diclofenac gel
Other Name: active comparator




Primary Outcome Measures :
  1. 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 (double-blind treatment group only)


Secondary Outcome Measures :
  1. WOMAC total score and WOMAC function and stiffness [ Time Frame: baseline, week 4 ]
    Change from baseline in 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) (double-blind treatment group only)

  2. ICOAP scores [ Time Frame: baseline, week 4 ]
    Change from baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) scores (score 0 [no pain]- 4 [extreme pain]) (double-blind treatment group only)

  3. WOMAC pain weight-bearing score and non-weight-bearing score [ Time Frame: baseline, week 4 ]
    Change from baseline in 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 (double-blind treatment group only)

  4. Physical function [ Time Frame: baseline, week 4 ]
    Change from baseline in physical function assessed by the chair-stand test (double-blind treatment group only)

  5. OMERACT-OARSI [ Time Frame: week 4 ]

    OMERACT-OARSI (Outcome Measures in Rheumatology

    - Osteoarthritis Research Society International) responder rate (double-blind treatment group only)


  6. Total dose of rescue medication [ Time Frame: weeks 1 through 4 ]
    Total dose of rescue medication calculated as the sum of tablets used, based on pill counts (double-blind treatment group only)

  7. Time between baseline and first use of rescue medication [ Time Frame: weeks 1 through 4 ]
    Time between baseline and first use of rescue medication (double-blind treatment group only)

  8. WOMAC pain sub-score (dose comparison) [ Time Frame: baseline, week 4 ]
    Change from baseline in WOMAC pain sub-score (questions 1 to 5; score 0-20) between groups receiving AMZ001 QD and BID in the target knee (double-blind treatment group only)

  9. ICOAP scores (dose comparison) [ Time Frame: baseline, week 4 ]
    Changes from baseline in constant and intermittent osteoarthritis pain assessed by ICOAP scores (0-44) between groups receiving AMZ001 QD and BID (double-blind treatment group only)

  10. WOMAC pain weight-bearing score and non-weight-bearing score (dose comparison) [ Time Frame: baseline, week 4 ]
    Changes from baseline in WOMAC pain weight-bearing score (questions 1, 2, and 5) and non-weight bearing score (questions 3 and 4) between groups receiving AMZ001 QD and BID (double-blind treatment group only)

  11. Physical function (dose comparison) [ Time Frame: baseline, week 4 ]
    Changes from baseline in physical function assessed by the chair-stand test between AMZ001 QD and BID (double-blind treatment group only)

  12. WOMAC total score and WOMAC function and stiffness (dose comparison) [ Time Frame: baseline, week 4 ]
    Changes from baseline in WOMAC total score and the WOMAC function and stiffness scores between AMZ001 QD and BID (double-blind treatment group only)

  13. Impact of osteoarthritis on daily living [ Time Frame: baseline, week 4 ]
    Changes from baseline in the impact of osteoarthritis on daily living as assessed by the Patient Global Assessment (PGA) score (0 [none] - 10 [extreme]) (double-blind treatment group only)

  14. Work productivity [ Time Frame: baseline, week 4 ]
    Changes from baseline in work productivity and activity assessed by the Work Productivity and Active Impairment (WPAI scores 0-100% in four different categories: absenteeism, presenteesism, work productivity loss, and activity impairment) (double-blind treatment group only)

  15. Change in quality of Life: EQ5D [ Time Frame: baseline, week 4 ]
    Changes from baseline in quality of life assessed by the EQ5D (score 0 [extremely poor] -100 [great] mm on a visual analogue scale) (double-blind treatment group only)


Other Outcome Measures:
  1. Safety endpoint (adverse events) [ Time Frame: weeks 1 through 4 ]
    Nature, incidence and severity of AEs

  2. Safety endpoint (change in sitting systolic or diastolic blood pressure) [ Time Frame: weeks 1 through 4 ]
    Changes in laboratory safety parameter vital signs (change in sitting systolic or diastolic blood pressure)

  3. Safety endpoint (change in sitting heart rate) [ Time Frame: weeks 1 through 4 ]
    Changes in laboratory safety parameter vital signs (change in sitting heart rate)

  4. Safety endpoint (change in body temperature) [ Time Frame: weeks 1 through 4 ]
    Changes in laboratory safety parameter vital signs (change in body temperature)

  5. Safety endpoint (12-lead ECG) [ Time Frame: weeks 1 through 4 ]
    Changes in laboratory safety parameter 12-lead ECG (ventricular rate, PR, QRS, QT, QTc interval)

  6. Safety endpoint (weight) [ Time Frame: weeks 1 through 4 ]
    Changes in laboratory safety parameter weight

  7. Safety endpoint (skin reactions) [ Time Frame: weeks 1 through 4 ]
    Nature, incidence, and severity of skin reactions on the application site



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Osteoarthritis of the knee, according the American College of Rheumatology (ACR) clinical and X-ray criteria.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Except for osteoarthritis, in reasonably good health as determined by the Investigator.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. High dose oral/injected 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. 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.
  7. Medical history of coronary artery bypass graft surgery.
  8. 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.
  9. Secondary osteoarthritis of the target knee, previous procedures or trauma affecting joint of the target knee.
  10. 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.
  11. Body Mass Index > 45.0 kg/m2.
  12. 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.
  13. Known presence of a ulcer or any gastrointestinal bleeding within 6 months prior to screening.
  14. Use of moderate or higher doses of opioid medication for the treatment of pain within 6 weeks before the screening visit.
  15. Use of duloxetine, pregabalin, or gabapentin within 4 weeks before the screening visit.
  16. History of alcohol or drug abuse within the past year prior to randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691844


Contacts
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Contact: Amzell 31 23 55 60 460 amzell-disclosure@amzell.com

Locations
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United States, Connecticut
Clinical Research Consulting Recruiting
Milford, Connecticut, United States, 06460
Contact: Amzell         
United States, Florida
Premier Medical Associates Recruiting
The Villages, Florida, United States, 32162
Contact: Amzell         
United States, New York
Upstate Clinical Research Associates Recruiting
Williamsville, New York, United States, 14221
Contact: Amzell         
Czechia
CCR Brno, s.r.o Active, not recruiting
Brno, Czechia
CCR Czech, a.s Active, not recruiting
Pardubice, Czechia
CCR Prague s.r.o. Active, not recruiting
Praha, Czechia
Denmark
Sanos Clinic Active, not recruiting
Herlev, Denmark
Sponsors and Collaborators
Amzell

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Responsible Party: Amzell
ClinicalTrials.gov Identifier: NCT03691844     History of Changes
Other Study ID Numbers: AMZ001-006
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amzell:
AMZ001

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action