A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
2021年11月5日 更新者：Teva Branded Pharmaceutical Products R&D, Inc.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients With Primary Osteoarthritis Affecting a Single Knee
The primary purpose of the study is to evaluate the change from baseline after 4 weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo for the relief of symptoms of primary OA affecting a single knee
調査の概要
研究の種類
介入
入学 (実際)
389
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Anaheim、California、アメリカ
- Teva Investigational Site 12217
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Anaheim、California、アメリカ
- Teva Investigational Site 12244
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Cerritos、California、アメリカ
- Teva Investigational Site 12252
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Cerritos、California、アメリカ
- Teva Investigational Site 13009
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El Cajon、California、アメリカ
- Teva Investigational Site 12233
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Lomita、California、アメリカ
- Teva Investigational Site 12240
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Sacramento、California、アメリカ
- Teva Investigational Site 12251
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Spring Valley、California、アメリカ
- Teva Investigational Site 12234
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Florida
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Clearwater、Florida、アメリカ
- Teva Investigational Site 12256
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DeLand、Florida、アメリカ
- Teva Investigational Site 12241
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Eustis、Florida、アメリカ
- Teva Investigational Site 12246
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Fort Myers、Florida、アメリカ
- Teva Investigational Site 12231
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Hialeah、Florida、アメリカ
- Teva Investigational Site 12216
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Jacksonville、Florida、アメリカ
- Teva Investigational Site 12230
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Miami、Florida、アメリカ
- Teva Investigational Site 12220
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Oldsmar、Florida、アメリカ
- Teva Investigational Site 12221
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Orlando、Florida、アメリカ
- Teva Investigational Site 12226
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Orlando、Florida、アメリカ
- Teva Investigational Site 12237
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Ormond Beach、Florida、アメリカ
- Teva Investigational Site 12255
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Plantation、Florida、アメリカ
- Teva Investigational Site 12225
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Sanford、Florida、アメリカ
- Teva Investigational Site 12229
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Tampa、Florida、アメリカ
- Teva Investigational Site 12235
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Georgia
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Atlanta、Georgia、アメリカ
- Teva Investigational Site 12253
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Marietta、Georgia、アメリカ
- Teva Investigational Site 12250
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Indiana
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Evansville、Indiana、アメリカ
- Teva Investigational Site 12243
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Kansas
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Overland Park、Kansas、アメリカ
- Teva Investigational Site 12238
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Louisiana
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New Orleans、Louisiana、アメリカ
- Teva Investigational Site 12218
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Massachusetts
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Watertown、Massachusetts、アメリカ
- Teva Investigational Site 12245
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Michigan
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Bingham Farms、Michigan、アメリカ
- Teva Investigational Site 12228
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Missouri
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Hazelwood、Missouri、アメリカ
- Teva Investigational Site 12242
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Saint Louis、Missouri、アメリカ
- Teva Investigational Site 12249
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Nebraska
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Omaha、Nebraska、アメリカ
- Teva Investigational Site 12223
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New York
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New York、New York、アメリカ
- Teva Investigational Site 12219
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North Carolina
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Charlotte、North Carolina、アメリカ
- Teva Investigational Site 12239
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Raleigh、North Carolina、アメリカ
- Teva Investigational Site 12248
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Winston-Salem、North Carolina、アメリカ
- Teva Investigational Site 12247
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Winston-Salem、North Carolina、アメリカ
- Teva Investigational Site 12254
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Ohio
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Cincinnati、Ohio、アメリカ
- Teva Investigational Site 12224
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Tennessee
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Memphis、Tennessee、アメリカ
- Teva Investigational Site 12236
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Texas
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Dallas、Texas、アメリカ
- Teva Investigational Site 12232
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Plano、Texas、アメリカ
- Teva Investigational Site 12227
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Virginia
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Charlottesville、Virginia、アメリカ
- Teva Investigational Site 12222
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patient is between 40 and 85 years of age, Patient has primary OA in a single knee (target knee) confirmed by American College of Rheumatology criteria.
- For patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics at the time of the screening visit,
- Patient has visual analog scale (VAS) pain scores with acceptable ranges as determined by the investigator during screening
- Except for OA, patient is judged by the investigator to be medically healthy and able to participate in the study.
- Other criteria apply, please contact the investigator for additional information
Exclusion Criteria:
- Patient has secondary or inflammatory arthritis of the knee such as psoriasis, rheumatoid arthritis (RA), gout, other primary bone disease, or acute trauma.
- Patient has symptomatic chondrocalcinosis
- Patient has a history of fibromyalgia.
- Patient has any painful or disabling conditions that in the opinion of the investigator may confound assessment of pain scoring.
- Patient has uncontrolled cardiac, renal, hepatic or other systemic disorders that in the opinion of the investigator may jeopardize the patient.
- Patient has significant edema or skin disorder (including sores, rashes, or ulcers) at the target knee and surrounding area.
- Patient has a history of total or partial knee replacement in either leg.
- Patient had a major reconstructive knee surgery or arthroscopy of the target knee within 6 months before the screening visit.
- Patient is unable or unwilling to discontinue opioid and/or other prescription analgesics for control of OA pain.
- Patient is intolerant to study drug, its excipients, and/or acetaminophen.
- Patient uses any over the counter oral medications such as glucosamine or chondroitin sulfate products, unless the patient has been receiving the medication for ≥3 months at the time of the screening visit and maintains the medication as stable therapy for the duration of the study.
- Other criteria apply, please contact the investigator for additional information
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：TV-45070 4%
TV-45070 ointment in a 4% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
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TV-45070 ointment administered twice a day (morning and evening) to target knee.
Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area.
The ointment was gently massaged into the skin.
他の名前：
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実験的：TV-45070 8%
TV-45070 ointment in a 8% strength applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
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TV-45070 ointment administered twice a day (morning and evening) to target knee.
Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area.
The ointment was gently massaged into the skin.
他の名前：
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プラセボコンパレーター：Placebo
Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
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Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee.
Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area.
The ointment was gently massaged into the skin.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline to Last 5 Days of Treatment in the Average Evening Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)
時間枠：Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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The Western Ontario and McMasters Universities Arthritis Index [WOMAC] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee.
It consists of 24 items separated into 3 domains (pain [5 items], stiffness [2 items], and physical function [17 items]).
WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface.
The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain).
Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours.
Negative change from baseline scores indicate improvement in pain.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor.
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Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline to Last 5 Days of Treatment in the Average Daily WOMAC Pain Subscale Score In the Target Knee Using a Mixed Model for Repeated Measures
時間枠：Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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The five items in the WOMAC Pain Subscale cover pain during walking, using stairs, in bed, sitting or lying, and standing.
Daily WOMAC pain subscale score is calculated as the sum of the 5-item pain subscale scores (WOMAC) recorded at evening for a total range of 0 (no pain) to 500 (worst pain on all 5 items).
Negative change from baseline scores indicate improvement in pain.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC scores for the 5-item pain subscale as a covariate; and patient as a random factor.
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Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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Change From Baseline to Last 5 Days of Treatment in the Average Morning Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)
時間枠：Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
|
The Western Ontario and McMasters Universities Arthritis Index [WOMAC] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee.
It consists of 24 items separated into 3 domains (pain [5 items], stiffness [2 items], and physical function [17 items]).
The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain).
WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface.
Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours.
Negative change from baseline scores indicate improvement in pain.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average morning WOMAC Question 1 score as a covariate; and patient as a random factor.
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Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Physical Function Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures
時間枠：Baseline (day 1, predose), Treatment: Week 4 (day 29)
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The seventeen items in the WOMAC physical function subscale cover stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.
WOMAC physical function subscale score is calculated as the sum of the 17-item physical function subscale scores (WOMAC) for a total range of 0 (no pain) to 1700 (worst pain on all 17 items).
Negative change from baseline scores indicate improvement in pain.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline physical function WOMAC scores for the 17-item subscale as a covariate; and patient as a random factor.
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Baseline (day 1, predose), Treatment: Week 4 (day 29)
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Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Stiffness Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures
時間枠：Baseline (day 1, predose), Treatment: Week 4 (day 29)
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The two items in the WOMAC stiffness subscale cover stiffness after first waking and later in the day.
WOMAC stiffness subscale score is calculated as the sum of the 2-item stiffness subscale scores (WOMAC) for a total range of 0 (no stiffness) to 200 (worst stiffness on both items).
Negative change from baseline scores indicate improvement in stiffness.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline stiffness WOMAC scores for the 2-item subscale as a covariate; and patient as a random factor.
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Baseline (day 1, predose), Treatment: Week 4 (day 29)
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Percentage of Participants With a >=30% and a >=50% Response in Average Evening Pain Intensity of WOMAC Question 1 in the Target Knee During the Last 5 Days of Treatment Compared With Baseline
時間枠：Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface.
The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain).
Average pain is calculated using a MMRM which includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor.
Responder rate was calculated as 100 * the value of (average WOMAC pain subscale during the last 5 days of treatment [Days 24 to 28]) - average WOMAC pain subscale at baseline [the 5 days prior to randomization])/average WOMAC pain subscale at baseline (the 5 days prior to randomization).
Participants with missing responder rates were treated as nonresponders.
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Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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Change From Baseline (Randomization Visit) to the Week 4 Visit in the Pain Quality Assessment Scale - Revised (PQAS-R) for the Target Knee Using a Mixed Model for Repeated Measures
時間枠：Baseline (day 1, predose), Treatment: Week 4 (day 29)
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PQAS-R is a standardized self-report tool that measures various aspects of a participant's pain.
There are 19 questions (question 19 has 2 parts) that ask the participant to rate the various aspects (intensity, sharpness, heat, cold, etc.) of his/her pain over the past week on average on a scale of 0 to 10 (0 = not [aspect] and 10 = the most or worst imaginable [aspect]).
PQAS-R score at each visit is the sum of responses for the 19 questions for a total range of 0=no pain to 200=worst imaginable pain in all aspects.
Negative change from baseline scores indicate improvement in stiffness.
MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline PQAS-R score for the 19 questions (20 parts) as a covariate; and patient as a random factor.
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Baseline (day 1, predose), Treatment: Week 4 (day 29)
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Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
時間枠：Weeks 2 (day 15), 4 (day 29)
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PGIC is a standardized self-report tool that measures the change in a participants overall status rating since the start of treatment on 7-point scale.
The 7-point scale is defined as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors and unconstructed variance-covariance structure.
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Weeks 2 (day 15), 4 (day 29)
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Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
時間枠：Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)
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PGA is a simple self-report tool for measuring the overall way arthritis is affecting the patient at a particular point in time.
There is 1 question and the response is provided on a visual analog scale (VAS) from 0 (very poor) to 100 (very good).
The question is: Considering all the ways your arthritis affect you, how are you feeling today?
Positive change from baseline scores indicate improvement.
The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors; baseline PGA score as a covariate and unconstructed variance-covariance structure.
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Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)
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Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4
時間枠：Week 4 (day 29)
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Participants are classified as 'Yes' if the following criteria are met: - >=50% improvement from baseline and an absolute change >=20 on a scale of 1-100 in either the pain or physical function subscale (WOMAC).
or 2 of the 3 criteria as below met: - 1) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the pain subscale (WOMAC); - 2) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the physical function subscale (WOMAC); - 3) at least a 20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in PGA.
Otherwise, 'No' The responder rate per OMERACT-OARSI criteria was analyzed using a generalized estimating equation (GEE) method, where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment*week as explanatory factors.
The unstructured working correlation structure was applied.
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Week 4 (day 29)
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Participants With Treatment-Emergent Adverse Events
時間枠：day 1 up to day 57
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An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Relationship of AE to treatment was determined by the investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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day 1 up to day 57
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Sr. Director, GCO, Theraputic Area Head、Teva Branded Pharmaceutical Products R&D, Inc.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年4月14日
一次修了 (実際)
2015年4月6日
研究の完了 (実際)
2015年5月4日
試験登録日
最初に提出
2014年2月19日
QC基準を満たした最初の提出物
2014年2月20日
最初の投稿 (見積もり)
2014年2月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月9日
QC基準を満たした最後の更新が送信されました
2021年11月5日
最終確認日
2021年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。