Injectable Diclofenac for the Prevention of Post-operative Dental Pain (DP4)
2014年8月28日 更新者:IBSA Institut Biochimique SA
Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.
研究概览
研究类型
介入性
注册 (实际的)
75
阶段
- 阶段2
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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Birmingham、英国、B4 6NN
- The School of Dentistry University of Birmingham
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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 至 65年 (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:
- Out-patients of either gender.
- Patients aged ≥ 18 to ≤ 65 years old.
- Subjects able and willing to give their written consent prior to inclusion in the study.
- Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
- Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
- Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
Exclusion Criteria:
General
- Patients refusing to give written informed consent.
- Patients not able to understand the purposes of the study or not willing to return for the control visits.
- Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
- Patients enrolled in any clinical trial in the previous 3 months.
- Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
- Pregnant or breast-feeding women.
- Alcohol or drug abuse in the previous 12 months.
- Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
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:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Diclofenac sodium 5 mg/mL
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One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
其他名称:
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实验性的:Diclofenac sodium 12.5 mg/mL
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One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
其他名称:
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实验性的:Diclofenac sodium 25 mg/mL
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One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
其他名称:
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实验性的:Diclofenac sodium 50 mg/mL
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One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
其他名称:
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安慰剂比较:Placebo 1 mL
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One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
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 |
---|---|---|
Area Under the Curve (AUC) of the Pain Scores.
大体时间:Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
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Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
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Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
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次要结果测量
结果测量 |
大体时间 |
---|---|
Postsurgical Extra-oral Swelling
大体时间:measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
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measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
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Trismus
大体时间:measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
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measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
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Peak Pain Intensity
大体时间:measured from end of surgery up to 12 hours postsurgery
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measured from end of surgery up to 12 hours postsurgery
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Time to First Use of Rescue Medication.
大体时间:measured from end of surgery up to 1 week postsurgery
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measured from end of surgery up to 1 week postsurgery
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Amount of Rescue Medication
大体时间:consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
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consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
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Rescue Medication Consumption
大体时间:consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
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consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
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Patient and Investigator Global Evaluation of the Effectiveness of Treatment
大体时间:at 6 hour postsurgery and on Day 3
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at 6 hour postsurgery and on Day 3
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Time to Onset of Pain
大体时间:measured from end of surgery up to 12 hours postsurgery
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measured from end of surgery up to 12 hours postsurgery
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Wound Healing
大体时间:at 6 hour postsurgery, and on day 3 and 1 week postsurgery
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at 6 hour postsurgery, and on day 3 and 1 week postsurgery
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Recurrent Bleeding
大体时间:every hour up to 6 hour postsurgery
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every hour up to 6 hour postsurgery
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Vital Signs
大体时间:presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
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presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
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Number of Patients With Adverse Events
大体时间:from signature of the informed consent to 1 week postsurgery
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from signature of the informed consent to 1 week postsurgery
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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
- 首席研究员:Thomas Dietrich, MD、The School of Dentistry, University of Birmingham
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2013年1月1日
初级完成 (实际的)
2013年5月1日
研究完成 (实际的)
2013年5月1日
研究注册日期
首次提交
2012年10月1日
首先提交符合 QC 标准的
2012年10月12日
首次发布 (估计)
2012年10月15日
研究记录更新
最后更新发布 (估计)
2014年9月5日
上次提交的符合 QC 标准的更新
2014年8月28日
最后验证
2014年8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.
Diclofenac sodium的临床试验
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