EUCTR2010-020380-20-ES进行中（未招募）1 期
Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
Janssen Research & Development, L.L.C.0 个研究点目标入组 44 人开始时间: 2012年6月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •1. Male or female subject from 12 to less than 18 years of age (Part 1 only) or male or female subject from 6 to less than 18 years of age (Part 2 only). Age is determined on the day of dosing of study medication.
- •2. BMI below the 95th percentile for children, based on CDC growth charts (see Attachments 1 and 2).
- •3. Criterion modified per amendment.
- •3.1. A maximum body weight of 85 kg. *
- •4. Criterion modified per amendment.
- •4.1. Having completed scheduled surgery per investigator?s judgment such as examples provided here but not limited to?? tonsillectomy, minor orthopedic procedures, corrective spinal or thoracic orthopedic surgeries, peripheral soft tissue procedure, uncomplicated inguinal hernia repair, minor urogenital procedure, ear surgery, eye surgery, peripheral plastic, dental or cosmetic surgery. Other surgical procedures may be allowed, based on investigator?s judgment, that will not result in heavy blood loss and/or a long and difficult recovery period. This list is not comprehensive, but provides potential examples of appropriate surgeries for inclusion in the
- •5. Criterion modified per amendment.
- •5.1. Having a postoperative pain intensity score ?4 on the McGrath CAS as a result of the scheduled surgical procedure; OR, if in the investigator?s clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the subject has a pain level that the standard of care following the surgical procedure (which reliably produces moderate
- •to severe pain) requires opioid treatment.
- •6. If applicable, has signed an Assent Form as per local regulations.
- •7. Parent(s) or the legal guardian(s) of the subject signed an informed consent
- •document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child?s participation in the study.
- •8. If a female, is premenarchal, surgically incapable of childbearing, abstinent, or, if sexually active, is practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before study entry and throughout the study.
- •9. If a female and postmenarchal or older than 12 years, has a negative urine pregnancy test on the day before or on the day of study drug administration.
- •10. Criterion modified per amendment.
- •10.1. If a male and sexually active, agrees to use an approved method of birth control to prevent pregnancy and, as applicable to relevant local regulations and medical practices, not to donate sperm from the day of study drug administration until 3 months afterwards.
- •11. Physical status rated as I or II as per the American Society of Anesthesiologists
- •(ASA) classification (see Attachment 3).
- •12. Is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age).
- •13. As per investigator?s medical evaluation, is able to drink and tolerate oral fluids and medication.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has been previously enrolled in this study (ie, subjects enrolled in part 1 may not
- •be enrolled in part 2 or vice versa).
- •2. Criterion modified per amendment.
- •2.1. The qualifying surgery involves a large body cavity (eg, opening the
- •abdominal, cardiac, or thoracic cavities and intervention of the organs
- •4. The qualifying surgery required prolonged ventilation and/or intensive care.
- •5. The qualifying surgery is upper or lower airway surgery.
- •6. The qualifying surgery is brain surgery.
- •7. Paralytic ileus.
- •8. Criterion modified per amendment.
- •8.1. Fever within 48 hours prior to dosing.
- •9. Criterion modified per amendment.
- •9.1. Mentally retarded, cognitively impaired or unable to comprehensively
- •understand or follow the study instructions, based on medical history or as
- •per investigator?s judgment.
- •10. Subjects currently taking medications that may be associated with the occurrence
- •of serotonin syndrome or seizures.
- •11. Subjects with conditions that may be associated with the occurrence of serotonin
- •syndrome or seizures.
- •12. History of any one of the following:
- •a. seizure disorder or epilepsy
- •b. serotonin syndrome
- •c. mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- •d. severe traumatic brain injury (consisting of 1 or more of the following: brain contusion; intracranial hematoma; or episode(s) of more than 24 hours duration of unconsciousness or posttraumatic amnesia) within 15 years of screening
- •e. Any traumatic or hypoxic brain injury resulting in ongoing sequelae
- •suggesting transient changes in consciousness or symptoms suggestive
- •f. moderate to severe renal or hepatic impairment
- •g. abnormal pulmonary function or respiratory disease (eg, clinically relevant
- •respiratory depression, acute or severe bronchial asthma, hypercapnia)
- •13. Criterion modified per amendment.
- •13.1. Has clinically relevant abnormal values for chemistry, hematology, or
- •urinalysis laboratory results prior to dosing. The following specifications
- •will apply:
- •a. >2 x ULN for AST or ALT,
- •b. >1.5 x ULN for total bilirubin,
- •c. >2 x ULN for creatinine,
- •d. other parameters as per the investigator?s judgment.
- •14. Has clinically relevant abnormal ECG as per the investigator?s judgment.
- •15. Requires concomitant use of sedatives, other than those used during surgery
- •(diphenhydramine administered for itching is exempted from this requirement).
- •16. Criterion modified per amendment.
- •16.1. Criterion modified per amendment.
- •16.2. Has had postoperative analgesia supplied by a continuous regional
- •technique (ie, ?nerve block?) or subject-controlled epidural analgesia within 2 hours of tapentadol administration.
- •17. Has a history of alcohol and/or drug abuse in the investigator?s judgment, based
- •on subject?s history and physical examination.
- •18. Has received an experimental drug or used an experimental medical device within 30 days prior to study drug administration, or within a period less than 10 times the drug?s half-life, whichever is longer.
- •19. Criterion modified per amendment.
- •19.1. Has received a potent inducer of hepatic drug-metabolizing enzyme activity
- •(eg, phenobarbital and rifampin) or neuroleptics, MAOIs, SSRIs, SNRIs, TCAs, triptans, anticonvulsants, antiparkinsonian drugs, and any drug that impairs metabolism of serotonin within 14 days before the scheduled study drug administration.
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