Tapentadol (CG5503)
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).
調査の概要
詳細な説明
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee.
The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US.
The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation).
The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity.
The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification.
The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase.
This will be done by looking at the patient's pain diary information.
Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients).
All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.
研究の種類
介入
入学 (実際)
1030
段階
- フェーズ 3
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
40年歳以上 (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:
- Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I-III
- patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
- Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
- baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Exclusion Criteria:
- History of alcohol and/or drug abuse in Investigator's judgement
- history of significant liver insufficiency
- chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
- life-long history of seizure disorder or epilepsy
- history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
- uncontrolled hypertension
- patients with severely impaired renal function
- patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：001
tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks
|
50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
|
|
アクティブコンパレータ：002
oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks
|
10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
|
|
プラセボコンパレーター：003
placebo matching placebo twice a day (BID) during 15 weeks
|
matching placebo twice a day (BID) during 15 weeks
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.
時間枠：Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
|
Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
時間枠：Baseline and 12 week endpoint
|
Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability
|
Baseline and 12 week endpoint
|
|
Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.
時間枠：Baseline and 12 week endpoint
|
A Sleep Questionniare addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency.
Decrease in time(hours) indicates improvement.
|
Baseline and 12 week endpoint
|
|
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
時間枠：Baseline and 12 week endpoint
|
Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)
|
Baseline and 12 week endpoint
|
|
Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy
時間枠：Baseline to 12 weeks
|
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint
|
Baseline to 12 weeks
|
|
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
時間枠：Baseline and 12 week endpoint
|
Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire.
A higher score indicates an improvement in health in the Health Status Index.
The EQ-5D is a five dimensional health state classification.
Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems).
The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead
|
Baseline and 12 week endpoint
|
|
Change From Baseline in Responder Analysis 50% Improvement to Week 12
時間枠：Baseline and Week 12
|
Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12.
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
|
Baseline and Week 12
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.
- Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
- Biondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y.
- Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.
- Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147.
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
2007年1月1日
一次修了 (実際)
2008年7月1日
研究の完了 (実際)
2008年12月1日
試験登録日
最初に提出
2007年1月12日
QC基準を満たした最初の提出物
2007年1月12日
最初の投稿 (見積もり)
2007年1月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年4月18日
QC基準を満たした最後の更新が送信されました
2012年4月16日
最終確認日
2012年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR013402
- R331333PAI3008 (その他の識別子：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
- KF11 (その他の識別子：Grunenthal GMBH)
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。
痛みの臨床試験
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Dexa Medica Group完了
tapentadol (CG5503)の臨床試験
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Johnson & Johnson Pharmaceutical Research & Development...完了
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Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbH完了
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Johnson & Johnson Pharmaceutical Research & Development...完了
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Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbH完了痛み | 腰痛 | 変形性関節症、膝 | 変形性関節症、股関節アメリカ, カナダ
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Johnson & Johnson Pharmaceutical Research & Development...完了
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Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbH完了関節炎 | 関節疾患 | 変形性関節症
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Janssen Research & Development, LLC完了
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Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbH完了
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Johnson & Johnson Pharmaceutical Research & Development...Grünenthal GmbH完了