Gel-200 Versus Placebo in Osteoarthritis of the Knee
3. oktober 2011 opdateret af: Seikagaku Corporation
A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.
The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
379
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Plantation, Florida, Forenede Stater, 33324
- SKK
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).
Exclusion Criteria:
- Subjects with Grade 4 on K-L score
- Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
- Serious systemic diseases
- Female subjects who are pregnant or lactating
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: PBS
|
Single intra-articular injection
|
|
Eksperimentel: Gel-200
|
Single intra-articular injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
Tidsramme: Baseline and Week 13
|
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in WOMAC VAS Stiffness Subscore
Tidsramme: Baseline and Week 13
|
Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
|
Change From Baseline in WOMAC VAS Physical Function Subscore
Tidsramme: Baseline and Week 13
|
Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
|
Change From Baseline in WOMAC VAS Total Score
Tidsramme: Baseline and Week 13
|
Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
|
Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response
Tidsramme: Weeks 6 to 13
|
Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).
|
Weeks 6 to 13
|
|
Change From Baseline in Short Form - 36 (SF-36)
Tidsramme: Baseline and Week 13
|
Scored on physical component scale from 0 (negative health) to 100 (positive health).
Calculated norm based with a mean of 50 and a standard deviation of 10.
|
Baseline and Week 13
|
|
Change From Baseline in Subject Global Evaluations
Tidsramme: Baseline and Week 13
|
Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
|
Change From Baseline in Physician Global Evaluations
Tidsramme: Baseline and Week 13
|
Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint.
Change in score from baseline to week 13 was calculated as baseline minus week 13.
Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
|
Baseline and Week 13
|
|
Acetaminophen Consumption
Tidsramme: Weeks 9 to 13 (5 weeks)
|
Weekly mean acetaminophen consumption between weeks 9 and 13.
|
Weeks 9 to 13 (5 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018.
- Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.
- Strand V, Baraf HSB, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2012 May;20(5):350-356. doi: 10.1016/j.joca.2012.01.013. Epub 2012 Feb 1.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. december 2007
Studieafslutning (Faktiske)
1. december 2007
Datoer for studieregistrering
Først indsendt
20. marts 2007
Først indsendt, der opfyldte QC-kriterier
20. marts 2007
Først opslået (Skøn)
21. marts 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. oktober 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2011
Sidst verificeret
1. oktober 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SI-6606/01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .