Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pai

• Conditions: Postoperative Pain; MedDRA version: 17.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; MedDRA version: 17.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-002016-27-Outside-EU/EEA
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• A maximum body weight of 85.0 kg.
• A minimum body weight of 10 kg for participants aged 2 years to less than 3 years old.
• If female and post-menarchal, or 12 years or older, the subject has a negative urine pregnancy test within 24 hours before surgery.
• Having completed either dental surgery or tonsillectomy with or without adenoidectomy surgery (age group: 6 to less than 18 years of age).
• Having completed ear, nose, or throat surgery (including but not limited to tonsillectomy (age group: 2 to less than 3 years of age).
• Participant aged 6 to less than 18 years has a post-operative pain intensity score greater than or equal to 4 on the Color Analog Scale (CAS) as a result of the surgical procedure or the participant has a pain level that the usual standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment.
• Participant aged 2 years to less than 6 years has a pain level following a surgical procedure that reliably produces moderate to severe pain, for which the usual standard of care requires opioid treatment.
• Participant is alert, orientated, and able to follow commands and complete the post-operative required procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range: 59
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

• History of brain injury.
• Clinically relevant abnormal ECG.
• Clinically unstable vital signs and/or a saturation of oxygen saturation (SpO2) less than 93%. During surgery SpO2 may decrease <93%.
• Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis at enrollment.
• Body temperature above 38.5°C within 48 hours prior to dosing.
• Positive drugs of abuse test result.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified