Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee

5. listopadu 2021 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

389

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Anaheim, California, Spojené státy
        • Teva Investigational Site 12217
      • Anaheim, California, Spojené státy
        • Teva Investigational Site 12244
      • Cerritos, California, Spojené státy
        • Teva Investigational Site 12252
      • Cerritos, California, Spojené státy
        • Teva Investigational Site 13009
      • El Cajon, California, Spojené státy
        • Teva Investigational Site 12233
      • Lomita, California, Spojené státy
        • Teva Investigational Site 12240
      • Sacramento, California, Spojené státy
        • Teva Investigational Site 12251
      • Spring Valley, California, Spojené státy
        • Teva Investigational Site 12234
    • Florida
      • Clearwater, Florida, Spojené státy
        • Teva Investigational Site 12256
      • DeLand, Florida, Spojené státy
        • Teva Investigational Site 12241
      • Eustis, Florida, Spojené státy
        • Teva Investigational Site 12246
      • Fort Myers, Florida, Spojené státy
        • Teva Investigational Site 12231
      • Hialeah, Florida, Spojené státy
        • Teva Investigational Site 12216
      • Jacksonville, Florida, Spojené státy
        • Teva Investigational Site 12230
      • Miami, Florida, Spojené státy
        • Teva Investigational Site 12220
      • Oldsmar, Florida, Spojené státy
        • Teva Investigational Site 12221
      • Orlando, Florida, Spojené státy
        • Teva Investigational Site 12226
      • Orlando, Florida, Spojené státy
        • Teva Investigational Site 12237
      • Ormond Beach, Florida, Spojené státy
        • Teva Investigational Site 12255
      • Plantation, Florida, Spojené státy
        • Teva Investigational Site 12225
      • Sanford, Florida, Spojené státy
        • Teva Investigational Site 12229
      • Tampa, Florida, Spojené státy
        • Teva Investigational Site 12235
    • Georgia
      • Atlanta, Georgia, Spojené státy
        • Teva Investigational Site 12253
      • Marietta, Georgia, Spojené státy
        • Teva Investigational Site 12250
    • Indiana
      • Evansville, Indiana, Spojené státy
        • Teva Investigational Site 12243
    • Kansas
      • Overland Park, Kansas, Spojené státy
        • Teva Investigational Site 12238
    • Louisiana
      • New Orleans, Louisiana, Spojené státy
        • Teva Investigational Site 12218
    • Massachusetts
      • Watertown, Massachusetts, Spojené státy
        • Teva Investigational Site 12245
    • Michigan
      • Bingham Farms, Michigan, Spojené státy
        • Teva Investigational Site 12228
    • Missouri
      • Hazelwood, Missouri, Spojené státy
        • Teva Investigational Site 12242
      • Saint Louis, Missouri, Spojené státy
        • Teva Investigational Site 12249
    • Nebraska
      • Omaha, Nebraska, Spojené státy
        • Teva Investigational Site 12223
    • New York
      • New York, New York, Spojené státy
        • Teva Investigational Site 12219
    • North Carolina
      • Charlotte, North Carolina, Spojené státy
        • Teva Investigational Site 12239
      • Raleigh, North Carolina, Spojené státy
        • Teva Investigational Site 12248
      • Winston-Salem, North Carolina, Spojené státy
        • Teva Investigational Site 12247
      • Winston-Salem, North Carolina, Spojené státy
        • Teva Investigational Site 12254
    • Ohio
      • Cincinnati, Ohio, Spojené státy
        • Teva Investigational Site 12224
    • Tennessee
      • Memphis, Tennessee, Spojené státy
        • Teva Investigational Site 12236
    • Texas
      • Dallas, Texas, Spojené státy
        • Teva Investigational Site 12232
      • Plano, Texas, Spojené státy
        • Teva Investigational Site 12227
    • Virginia
      • Charlottesville, Virginia, Spojené státy
        • Teva Investigational Site 12222

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: TV-45070
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.
Ostatní jména:
  • funapide
  • XEN402
Experimentální: 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.
Lék: TV-45070
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.
Ostatní jména:
  • funapide
  • XEN402
Komparátor placeba: Placebo
Placebo ointment applied topically twice daily to the target knee during the treatment period from day 1 through day 28.
Lék: Placebo
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
Časové okno: 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]). 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.
Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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.
Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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)
Časové okno: 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.
Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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
Časové okno: Baseline (day 1, predose), Treatment: Week 4 (day 29)
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.
Baseline (day 1, predose), Treatment: Week 4 (day 29)
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
Časové okno: Baseline (day 1, predose), Treatment: Week 4 (day 29)
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.
Baseline (day 1, predose), Treatment: Week 4 (day 29)
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
Časové okno: Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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.
Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)
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
Časové okno: Baseline (day 1, predose), Treatment: Week 4 (day 29)
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.
Baseline (day 1, predose), Treatment: Week 4 (day 29)
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)
Časové okno: Weeks 2 (day 15), 4 (day 29)
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.
Weeks 2 (day 15), 4 (day 29)
Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)
Časové okno: Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)
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.
Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)
Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4
Časové okno: Week 4 (day 29)
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.
Week 4 (day 29)
Participants With Treatment-Emergent Adverse Events
Časové okno: day 1 up to day 57
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.
day 1 up to day 57

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Teva Branded Pharmaceutical Products R&D, Inc.

Vyšetřovatelé

  • Ředitel studie: Sr. Director, GCO, Theraputic Area Head, Teva Branded Pharmaceutical Products R&D, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. dubna 2014

Primární dokončení (Aktuální)

6. dubna 2015

Dokončení studie (Aktuální)

4. května 2015

Termíny zápisu do studia

První předloženo

19. února 2014

První předloženo, které splnilo kritéria kontroly kvality

20. února 2014

První zveřejněno (Odhad)

21. února 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2021

Naposledy ověřeno

1. listopadu 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TV-45070-CNS-20005

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Osteoartróza kolene

Klinické studie na TV-45070

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Bosnia & Herzegovina

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit