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An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

2013年5月10日 更新者：Janssen Pharmaceutical K.K.

Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study.

研究の種類

介入

入学 (実際)

91

段階

  • フェーズ2

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

  • 日本
      • Aichi、日本
      • Amagasaki、日本
      • Chiba、日本
      • Chiba N/A、日本
      • Chikushi、日本
      • Edogawa、日本
      • Fukuoka、日本
      • Fukushima、日本
      • Hiratsuka、日本
      • Kawasaki、日本
      • Koto、日本
      • Matsudo、日本
      • Meguro、日本
      • Minato-Ku、日本
      • Niigata、日本
      • Niigata N/A、日本
      • Osaka、日本
      • Sagamihara、日本
      • Shibuya、日本
      • Shinjuku-Ku、日本
      • Toshima-Ku、日本

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

20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:

  • Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
  • Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
  • Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
  • Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
  • Participants who are able to visit the medical institutions throughout the study period

Exclusion Criteria:

  • Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
  • Participants with current or a history of epilepsy or seizure disorders
  • Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
  • Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
  • Participants with moderate to severe liver dysfunction or severe renal dysfunction

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
プラセボコンパレーター：プラセボ
薬：Placebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
実験的：Tapentadol Hydrochloride
薬：Tapentadol Hydrochloride
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

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 in 11-point Numerical Rating Scale (NRS) at Week 12
時間枠：Baseline, Week 12
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Baseline, Week 12

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 11-point Numerical Rating Scale (NRS)
時間枠：Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
時間枠：Week 12
Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
Week 12
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
時間枠：Week 8, Week 12
The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Week 8, Week 12
Number of Participants With Response Based on Physician's Global Assessment Scale
時間枠：Week 8, Week 12
Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".
Week 8, Week 12
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
時間枠：Baseline, Week 12
BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".
Baseline, Week 12
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
時間枠：Baseline, Week 12
BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).
Baseline, Week 12
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
時間枠：Baseline, Week 12
BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.
Baseline, Week 12
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
時間枠：Baseline, Week 12
Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.
Baseline, Week 12
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
時間枠：Baseline, Week 12
Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.
Baseline, Week 12
Number of Participants With Awakenings Based on Sleep Questionnaire
時間枠：Baseline, Week 12
Number of awakenings was addressed by the question: "How many times did you wake up during the night?'' and lesser number signified better sleep.
Baseline, Week 12
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
時間枠：Baseline, Week 12
Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.
Baseline, Week 12
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
時間枠：Baseline, Week 12
SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Baseline, Week 12
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
時間枠：Baseline, Week 12
WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.
Baseline, Week 12
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
時間枠：Baseline, Week 12
RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.
Baseline, Week 12

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
時間枠：Week 12
COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.
Week 12
Serum Concentration of Tapentadol
時間枠：Week 2, 4, 8, 12
Week 2, 4, 8, 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。

スポンサー

Janssen Pharmaceutical K.K.

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

2010年4月1日

一次修了 (実際)

2010年12月1日

研究の完了 (実際)

2010年12月1日

試験登録日

最初に提出

2010年4月22日

QC基準を満たした最初の提出物

2010年5月13日

最初の投稿 (見積もり)

2010年5月17日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年5月14日

QC基準を満たした最後の更新が送信されました

2013年5月10日

最終確認日

2013年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CR016999
  • JNS024ER-JPN-N21 (その他の識別子：Janssen Pharmaceutical K.K., Japan)

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

Tapentadol Hydrochlorideの臨床試験

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