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A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis

8 augusti 2012 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

43

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 001
JNJ-39439335 2 x 5 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
Experimentell: 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
Övrig: 003
Naproxen 500 mg capsule every 12 hours for 21 days
500 mg capsule every 12 hours for 21 days
Placebo-jämförare: 004
Placebo Placebo tablet/capsule every 12 hours for 21 days
Placebo tablet/capsule every 12 hours for 21 days

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Number of participants with adverse events as a measure of safety and tolerability
Tidsram: 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
Tidsram: From Day -1 up to final follow up visit
From Day -1 up to final follow up visit
Change from baseline in ECG
Tidsram: From Day -1 up to final follow up visit
From Day -1 up to final follow up visit
Change from baseline in clinical laboratory tests
Tidsram: From Day -1 up to final follow up visit
From Day -1 up to final follow up visit
Concentaton of JNJ-39439335 in blood and urine samples
Tidsram: From Day 1 up to final follow up visit
From Day 1 up to final follow up visit
Concentration of JNJ-39439335 in blood and urine samples
Tidsram: From Day 1 up to final follow up visit
From Day 1 up to final follow up visit

Sekundära resultatmått

Resultatmått
Tidsram
Change from baseline in pain numerical rating scale
Tidsram: From Day 2 up to final follow up visit
From Day 2 up to final follow up visit
Change from baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Tidsram: From Day -1 up to final follow up visit
From Day -1 up to final follow up visit

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2011

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

7 april 2011

Först inskickad som uppfyllde QC-kriterierna

26 april 2011

Första postat (Uppskatta)

28 april 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 augusti 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 augusti 2012

Senast verifierad

1 augusti 2012

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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