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Phase 1 Completed N=47 Randomized Quadruple-blind Other

A Study to Characterize Diclofenac's Plasma and Knee Exposure After Application of Diclofenac Gel to the Knee of Subjects With Osteoarthritis That Have a Scheduled Arthroplasty

Source: ClinicalTrials.gov NCT03497039 ↗
Enrolled (actual)
47
Serious AEs
2.2%
Results posted
Feb 2020
Primary outcomePrimary: Diclofenac Concentration in Treated Knee Synovial Tissue After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment) — 1.573; NA nanograms per gram (ng/g)

Summary

The purpose of this study is to evaluate the exposure of diclofenac in the plasma and in the knee joint following topical administration of DDEA gel 4 gram (g) applied twice daily for 7 days.

Outcome Measures

OutcomeResultp-value
PRIMARY
Diclofenac Concentration in Treated Knee Synovial Tissue After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)
1.573; NA
PRIMARY
Diclofenac Concentration in Treated Knee Synovial Fluid After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)
2.274; NA
SECONDARY
Ratio Between Diclofenac Concentration in Treated Knee Synovial Tissue and Plasma After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)
0.320; NA
SECONDARY
Ratio Between Diclofenac Concentration in Treated Knee Synovial Fluid and Plasma After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)
0.463; NA

Eligibility Criteria

Inclusion Criteria

  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Male and female participants who, at the time of screening, are ≥ 50 years of age.
  • Participant has a diagnosis of OA of the knee requiring arthroplasty and is scheduled for single knee arthroplasty, with radiographic evidence within last 6 months confirming Kellgren Lawrence grade of 2 or more.
  • Participant is in general good physical health and deemed fit for surgery, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, respiratory rate and temperature measurement, 12 lead ECG or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to less than 40 kg/m2; and a total body weight >50 kg (110 lbs).
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 21 days after the last dose of assigned treatment. Female participants who are not of childbearing potential must meet following requirements: Female participants who are of childbearing potential and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception consistently and correctly for the duration of the active study period (onwards from screening) and for at least 21 days after the last dose of investigational product. The investigator or his or her designee, in consultation with the participant, will confirm that the participant has selected an appropriate method of contraception for the individual participant from the permitted list of contraception methods (see below) and instruct the participant in its consistent and correct use. Participants need to affirm that they meet the criteria for the correct use of at least 1 of the selected methods of contraception. The investigator or his or her designee will discuss with the participant the need to use highly effective contraception consistently and correctly according to the schedule of activities and document such conversation in the participant's chart. In addition, the investigator or his or her designee will instruct the participant to call immediately if the selected contraception method is discontinued or if pregnancy is known or suspected in the participant. Highly effective methods of contraception are those that, alone or in combination, result in a failure rate of less than 1% per year when used consistently and correctly (i.e., perfect use) and include the following a)Established use of oral, inserted, injected, transdermal, or implanted hormonal methods of contraception is allowed provided the participant plans to remain on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness as deemed appropriate by the investigator, b) Correctly placed copper-containing intrauterine device (IUD), c) Male condom or female condom used with a spermicide (i.e., foam, gel, film, cream, or suppository), d) Male sterilization with absence of sperm in the post-vasectomy ejaculate e) Bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusive procedure (provided that occlusion has been confirmed in accordance with the device's label), f)Female who meets the criteria for non-childbearing potential as described below. Female participants of non-childbearing potential must meet at least one of the following criteria: 1) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or phy
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Data sourced from ClinicalTrials.gov (NCT03497039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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