A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
2012年8月8日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
43
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
George、南アフリカ
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
実験的：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
|
|
他の：003
Naproxen 500 mg capsule every 12 hours for 21 days
|
500 mg capsule every 12 hours for 21 days
|
|
プラセボコンパレーター：004
Placebo Placebo tablet/capsule every 12 hours for 21 days
|
Placebo tablet/capsule every 12 hours for 21 days
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of participants with adverse events as a measure of safety and tolerability
時間枠：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
時間枠：From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
|
Change from baseline in ECG
時間枠：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
時間枠：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
時間枠：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
時間枠：From Day 1 up to final follow up visit
|
From Day 1 up to final follow up visit
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in pain numerical rating scale
時間枠：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)
時間枠：From Day -1 up to final follow up visit
|
From Day -1 up to final follow up visit
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2011年4月7日
QC基準を満たした最初の提出物
2011年4月26日
最初の投稿 (見積もり)
2011年4月28日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月9日
QC基準を満たした最後の更新が送信されました
2012年8月8日
最終確認日
2012年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。