- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01343303
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
8. august 2012 oppdatert av: Janssen Research & Development, LLC
A Double-Blind, Randomized, Placebo-and Active-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Subjects With Osteoarthritis
The purpose of this study is to evaluate the safety of multiple oral doses of JNJ-39439335 and to assess how JNJ-39439335 is absorbed (taken in), distributed, metabolized (broken down), and eliminated from the body (referred to as pharmacokinetics) in osteoarthritis patients.
This study will also assess the effectiveness of JNJ-39439335 on pain.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This will be a double-blind (patient and study staff will not know the identity of assigned treatment), randomized (assignment to 1 to 3 treatment groups will be by chance, like "flipping a coin"), placebo-controlled, multiple dose study conducted at up to two clinical sites.
Up to 42 patients with osteoarthritis of the knee will be enrolled in 3 cohorts (Cohort 1 to 3).
Additional cohorts (up to 14 patients per cohort) may be added after completion of Cohort 3. The study consists of eligibility screening, a treatment phase, and 4 follow-up visits.
The study duration for each patient will be approximately 10 weeks.
Patients safety will be closely monitored during the study by review of adverse events, electrocardiograms, vital signs (including oral temperature), clinical laboratory tests, and physical examinations.
During specified study visits, blood samples will be collected for pharmacokinetics, pharmacodynamics (inpatient patients), and pharmacogenomic (optional) evaluations of JNJ-39439335.
The effectiveness of JNJ-39439335 will be evaluated by assessing pain using an 11-point numerical rating scale and by the Western Ontario and McMaster Osteoarthritis Index.
In Cohort 1 and 2, all patients will take their study medication orally, twice a day for 21 days.
The treatment groups for Cohort 1 are JNJ-39439335 10 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 2 are JNJ-39439335 25 mg, naproxen 500 mg every 12 hours, and placebo.
The treatment groups for Cohort 3 will be determined based on the results of Cohort 1 and 2.
Studietype
Intervensjonell
Registrering (Faktiske)
43
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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George, Sør-Afrika
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Nonsmoker >= 6 months prior to first dose
- body mass index (BMI) <= 36 kg/m2
- Meet American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement, no palpable warmth of synovium
- Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid analgesic for OA knee pain daily for >=5 days prior to screening with benefit
- Otherwise healthy based on physical exam, medical history, vital signs, 12-lead electrocardiogram (ECG), can clinical laboratory tests
- Women must be postmenopausal or surgically sterile.
Exclusion Criteria:
- Oral temperature >37.5 deg C at Screening or Day -1
- Failure of burn prevention measures quiz at Screening
- patients with occupations or hobbies in which they are routinely exposed to situations in which they could sustain burns
- orthopedic and/or prosthetic device on target knee joint
- Significant pain outside the target knee, including significant hip or back pain (bilateral knee OA is permitted)
- Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs (NSAIDS) other than paracetamol during the study
- Surgical intervention for any pain within 3 months prior to screening or has plans for surgical intervention while in the study
- History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
- Treatment with local corticosteroid injections or viscosupplementation in target joint, or use of oral or intramuscular corticosteroids, within 3 months prior to Screening
- History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or duodenal ulcer within 3 months prior to screening or any other condition, which in the Investigator's opinion, precludes use of an NSAID.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 001
JNJ-39439335 2 x 5 mg tablets once daily for 21 days
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2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
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|
Eksperimentell: 002
JNJ-39439335 2 x 25 mg tablets once daily for 21 days
|
2 x 25 mg tablets once daily for 21 days
2 x 5 mg tablets once daily for 21 days
|
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Annen: 003
Naproxen 500 mg capsule every 12 hours for 21 days
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500 mg capsule every 12 hours for 21 days
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Placebo komparator: 004
Placebo Placebo tablet/capsule every 12 hours for 21 days
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Placebo tablet/capsule every 12 hours for 21 days
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants with adverse events as a measure of safety and tolerability
Tidsramme: From screening up to final follow up visit.
|
From screening up to final follow up visit.
|
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Change from baseline in vital signs, including oral body temperature
Tidsramme: From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
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Change from baseline in ECG
Tidsramme: From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Change from baseline in clinical laboratory tests
Tidsramme: From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Concentaton of JNJ-39439335 in blood and urine samples
Tidsramme: From Day 1 up to final follow up visit
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From Day 1 up to final follow up visit
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Concentration of JNJ-39439335 in blood and urine samples
Tidsramme: From Day 1 up to final follow up visit
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From Day 1 up to final follow up visit
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in pain numerical rating scale
Tidsramme: From Day 2 up to final follow up visit
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From Day 2 up to final follow up visit
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Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Tidsramme: From Day -1 up to final follow up visit
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From Day -1 up to final follow up visit
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
7. april 2011
Først innsendt som oppfylte QC-kriteriene
26. april 2011
Først lagt ut (Anslag)
28. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. august 2012
Sist bekreftet
1. august 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Revmatiske sykdommer
- Leddgikt
- Artrose
- Artrose, kne
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Syklooksygenase-hemmere
- Giktdempende midler
- Naproxen
Andre studie-ID-numre
- CR018292
- 39439335EDI1014 (Annen identifikator: Janssen Research & Development, LLC)
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