Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
2019年11月4日 更新者：BioDelivery Sciences International
A Double-blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy.
The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness.
Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products.
Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer.
OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes).
The buccal route of administration avoids the delay and variability associated with oral absorption.
研究概览
详细说明
This is a randomized, double-blind, placebo controlled, multiple cross-over study.
Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks.
Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes.
Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial.
They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.
研究类型
介入性
注册 (实际的)
152
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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North Carolina
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Wilmington、North Carolina、美国、28412
- PPD Development
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
- 18 years or older
- Patient must have pain associated with cancer or cancer treatment.
- Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg).
- Regularly experiences 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
- At least partial relief of breakthrough pain by use of opioid therapy
- Subject must be able to self-administer the study medication correctly.
- Subject must be willing and able to complete the electronic diary card with each pain episode.
- Signed consent must be obtained at screening prior to any procedures being performed.
Exclusion Criteria:
- Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
- Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
- Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
- Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
- Moderate (Grade 3) to severe (Grade 4) mucositis (Subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation.)
- Strontium 89 therapy within the previous 6 months
- Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
- Use of an investigational drug within 4 weeks preceding this study
- History of hypersensitivity or intolerance to fentanyl
- Regularly more than 4 episodes per day
- Eastern Cooperative Oncology Group (ECOG) performance status of 4 or 5
- Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form.
The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth.
The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened.
The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
其他名称：
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实验性的：BEMA™ Fentanyl
BioErodible MucoAdhesive (BEMA) Fentanyl
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BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form.
The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth.
The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened.
The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Summary of Pain Intensity Differences (SPID)
大体时间：0-30 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. |
0-30 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SPID
大体时间：0-5 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-5 minutes
|
|
SPID
大体时间：0-10 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-10 minutes
|
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SPID
大体时间：0-15 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-15 minutes
|
|
SPID
大体时间：0-45 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-45 minutes
|
|
SPID
大体时间：0-60 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.
|
0-60 minutes
|
|
PID
大体时间：5 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
5 minutes after dosing
|
|
PID
大体时间：10 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
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10 minutes after dosing
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PID
大体时间：15 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
15 minutes after dosing
|
|
PID
大体时间：30 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
30 minutes after dosing
|
|
PID
大体时间：45 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
45 minutes after dosing
|
|
PID
大体时间：60 minutes after dosing
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
|
60 minutes after dosing
|
|
Pain Relief
大体时间：5 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
5 minutes after dosing
|
|
Pain Relief
大体时间：10 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
10 minutes after dosing
|
|
Pain Relief
大体时间：15 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
15 minutes after dosing
|
|
Pain Relief
大体时间：30 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
30 minutes after dosing
|
|
Pain Relief
大体时间：45 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
45 minutes after dosing
|
|
Pain Relief
大体时间：60 minutes after dosing
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.
|
60 minutes after dosing
|
|
Total Pain Relief
大体时间：5 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
5 minutes
|
|
Total Pain Relief
大体时间：10 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
10 minutes
|
|
Total Pain Relief
大体时间：15 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
15 minutes
|
|
Total Pain Relief
大体时间：30 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
30 minutes
|
|
Total Pain Relief
大体时间：45 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
45 minutes
|
|
Total Pain Relief
大体时间：60 minutes
|
Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)
|
60 minutes
|
|
Subject Overall Satisfaction With Study Drug
大体时间：60 minutes or at time of rescue medication use
|
Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).
|
60 minutes or at time of rescue medication use
|
|
Percentage of Pain Free Episodes
大体时间：5 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
5 minutes
|
|
Percentage of Pain Free Episodes
大体时间：10 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
10 minutes
|
|
Percentage of Pain Free Episodes
大体时间：15 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
15 minutes
|
|
Percentage of Pain Free Episodes
大体时间：30 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
30 minutes
|
|
Percentage of Pain Free Episodes
大体时间：45 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
45 minutes
|
|
Percentage of Pain Free Episodes
大体时间：60 minutes
|
A pain free episode is one with 0 pain intensity at the specified time point.
Percentage of episodes that are pain-free per subject is analyzed.
|
60 minutes
|
|
Episodes With at Least 50% Decreases in Pain
大体时间：15 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
15 minutes
|
|
Episodes With at Least 50% Decreases in Pain
大体时间：30 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
30 minutes
|
|
Episodes With at Least 50% Decreases in Pain
大体时间：45 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
45 minutes
|
|
Episodes With at Least 50% Decreases in Pain
大体时间：60 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
60 minutes
|
|
Episodes With at Least 33% Decreases in Pain
大体时间：15 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
15 minutes
|
|
Episodes With at Least 33% Decreases in Pain
大体时间：30 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
30 minutes
|
|
Episodes With at Least 33% Decreases in Pain
大体时间：45 minutes
|
Number of episodes where the total pain score has at least a 33% reduction from baseline.
|
45 minutes
|
|
Episodes With at Least 33% Decreases in Pain
大体时间：60 minutes
|
Number of episodes where the total pain score has at least a 50% reduction from baseline.
|
60 minutes
|
|
Episodes With Complete Pain Relief
大体时间：5 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
5 minutes
|
|
Episodes With Complete Pain Relief
大体时间：10 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
10 minutes
|
|
Episodes With Complete Pain Relief
大体时间：15 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
15 minutes
|
|
Episodes With Complete Pain Relief
大体时间：30 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
30 minutes
|
|
Episodes With Complete Pain Relief
大体时间：45 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
45 minutes
|
|
Episodes With Complete Pain Relief
大体时间：60 minutes
|
Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).
Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.
|
60 minutes
|
|
Rescue Medication Usage
大体时间：28 Days
|
Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug.
Percentage of episodes when rescue medication was used per subject is analyzed.
|
28 Days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SPID in Neuropathic Pain Subpopulation
大体时间：15 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
15 minutes
|
|
SPID in Neuropathic Pain Subpopulation
大体时间：30 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
30 minutes
|
|
SPID in Neuropathic Pain Subpopulation
大体时间：45 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
45 minutes
|
|
SPID in Neuropathic Pain Subpopulation
大体时间：60 minutes
|
Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing.
Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.
The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study.
SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes).
Higher value indicates a better outcome.
SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes).
Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.
|
60 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Andrew Finn, PharmD、BioDelivery Sciences International
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年2月1日
初级完成 (实际的)
2007年4月1日
研究完成 (实际的)
2007年4月1日
研究注册日期
首次提交
2006年2月15日
首先提交符合 QC 标准的
2006年2月15日
首次发布 (估计)
2006年2月17日
研究记录更新
最后更新发布 (实际的)
2019年11月18日
上次提交的符合 QC 标准的更新
2019年11月4日
最后验证
2019年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的