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Clinical Trials/EUCTR2010-020380-20-Outside-EU/EEA
EUCTR2010-020380-20-Outside-EU/EEAActive, not recruitingNot Applicable

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 sites40 target enrollmentStarted: March 9, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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
  • •3. A maximum body weight of 85 kg.
  • •4. Having completed scheduled surgery per investigator’s judgment such as examples provided here but not limited to tonsillectomy, minor orthopedic procedure, corrective spinal or thoracic orthopedic surgeries, peripheral soft tissue procedure, uncomplicated inguinal hernia repair, minor urogenital procedure, ear surgery, eye surgery, peripheral plastic, 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.
  • •5. Having a postoperative pain intensity score = 4 on the McGrath CAS as a result of the scheduled surgical procedure.
  • •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 (e.g., 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. 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.
  • •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: 40
  • •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

Exclusion Criteria

  • •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. The qualifying surgery involves a large body cavity (e.g. opening the abdominal, cardiac, or thoracic cavities and intervention of the organs therein).
  • •3. The qualifying surgery required prolonged ventilation and/or intensive care.
  • •4. The qualifying surgery is upper or lower airway surgery.
  • •5. The qualifying surgery is brain surgery.
  • •6. Has significant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders or any other clinically significant disease that in the Investigator's opinion may affect or compromise subject safety during the trial participation.
  • •7. Paralytic ileus.
  • •8. Fever within 1 week prior to tapentadol administration.
  • •9. Mentally retarded, cognitively impaired or unable to comprehensively understand or follow the study instructions, as per investigator’s judgment or based on medical history
  • •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 thereof
  • •f. moderate to severe renal or hepatic impairment
  • •g. abnormal pulmonary function or respiratory disease (e.g., clinically relevant respiratory depression, acute or severe bronchial asthma, hypercapnia)
  • •13. Has clinically relevant abnormal values for chemistry, hematology, or urinalysis
  • •laboratory results at screening. 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. Has had postoperative analgesia supplied by a continuous regional technique (ie. nerve block”)or
  • •subject-controlled epidural analgesia.
  • •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 timesthe drug’s half-life, whichever is longer.
  • •19. 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.
  • •20. Has received dextromethorphan within 2 days before the scheduled study drug administration.
  • •21. Has had p

Investigators

Sponsor
Janssen Research & Development, L.L.C.

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