A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
8 augustus 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
43
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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George, Zuid-Afrika
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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|
Experimenteel: 002
JNJ-39439335 2 x 25 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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Ander: 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-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of participants with adverse events as a measure of safety and tolerability
Tijdsspanne: From screening up to final follow up visit.
|
From screening up to final follow up visit.
|
|
Change from baseline in vital signs, including oral body temperature
Tijdsspanne: 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 ECG
Tijdsspanne: 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 clinical laboratory tests
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From Day 1 up to final follow up visit
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From Day 1 up to final follow up visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change from baseline in pain numerical rating scale
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2011
Studie voltooiing (Werkelijk)
1 december 2011
Studieregistratiedata
Eerst ingediend
7 april 2011
Eerst ingediend dat voldeed aan de QC-criteria
26 april 2011
Eerst geplaatst (Schatting)
28 april 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
9 augustus 2012
Laatste update ingediend die voldeed aan QC-criteria
8 augustus 2012
Laatst geverifieerd
1 augustus 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Reumatische aandoeningen
- Artritis
- Artrose
- Artrose, knie
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Agenten van het perifere zenuwstelsel
- Enzymremmers
- Pijnstillers
- Sensorische systeemagenten
- Ontstekingsremmers, niet-steroïde
- Pijnstillers, niet-narcotisch
- Ontstekingsremmende middelen
- Antireumatische middelen
- Cyclo-oxygenaseremmers
- Jicht onderdrukkende middelen
- Naproxen
Andere studie-ID-nummers
- CR018292
- 39439335EDI1014 (Andere identificatie: Janssen Research & Development, LLC)
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