EUCTR2013-002016-27-Outside-EU/EEA
Active, not recruiting
Not Applicable
Open-label evaluation of the pharmacokinetic profile, safety, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children and adolescents aged from 2 years to less than 18 years.
ConditionsPostoperative PainMedDRA version: 17.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 17.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Grünenthal GmbH
- Enrollment
- 59
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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