An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY)
Objectives:
Objective of main interest
- To assess the drop-out rate caused by adverse event* after 6 weeks treatment
Further objectives
- To assess the drop-out rate caused by adverse event* after 1 week treatment
- To assess the pain reduction rate after 6 weeks treatment from baseline
- To assess the Euroquol (EQ-5D) quality of life
- To assess physician's overall satisfaction
- To assess subject's overall satisfaction
- To assess safety
調査の概要
詳細な説明
Study Design (Methodology):
This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Seoul、大韓民国
- AMC
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female ≥ 20 and <80 years of age
- Patients who have non-malignant chronic pain(≥90 days)
- Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
- Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
- Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
- Patients who signed a written informed consent form
Exclusion Criteria:
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
- Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
- Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
研究計画
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Group A
Start oxycodone/naloxone 10/5mg b.i.d.
titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
|
Oxycodone/naloxone titration
他の名前：
|
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他の：Group B
Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
|
Oxycodone/naloxone titration
他の名前：
|
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 |
|---|---|---|
|
Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
時間枠：6 weeks
|
To assess the drop-out rate caused by adverse event* after 6 weeks treatment
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6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
時間枠：1 week
|
The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.
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1 week
|
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The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
時間枠：6 weeks
|
Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks.
NRS score was measured from 0 (No pain) to 10(worst pain imaginable).
|
6 weeks
|
|
Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
時間枠：6 weeks
|
EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life. |
6 weeks
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Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
時間枠：6 weeks
|
Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.
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6 weeks
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Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
時間枠：6weeks
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At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).
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6weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Hoseong Lee, Dr.、Asan Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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