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

Overview[ - collapse ][ - ]

Purpose To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose. Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.
ConditionPostoperative Pain
Acute Pain
InterventionDrug: Tapentadol
PhasePhase 2
SponsorGrünenthal GmbH
Responsible PartyGrünenthal GmbH
ClinicalTrials.gov IdentifierNCT01729728
First ReceivedNovember 6, 2012
Last UpdatedMarch 4, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateNovember 6, 2012
Last Updated DateMarch 4, 2014
Start DateNovember 2012
Estimated Primary Completion DateFebruary 2014
Current Primary Outcome MeasuresPharmacokinetic profile of tapentadol after a single dose of tapentadol oral solution in children and adolescents age 2 to less than 18 years. [Time Frame: 15 hours] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change from baseline of physical examination [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Change from baseline of ECG [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Change from baseline in safety laboratory [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Change from baseline of respiratory rate, blood pressure and heart rate [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Change from baseline in oxygen saturation [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Number of patients with adverse events [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Number and intensity of adverse events [Time Frame: 15 hours] [Designated as safety issue: Yes]
  • Change from baseline in Pain intensity [Time Frame: 15 hours] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitlePharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
Official TitleOpen-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.
Brief Summary
To find out if a drug called tapentadol administered by mouth safely relieves pain in
children. Look at the amount of tapentadol in the blood after a single oral dose.

Tapentadol oral solution for children is still being tested and is not yet registered.
Tapentadol tablets are effective in treating both acute and chronic pain in adults. This
trial will help to understand how tapentadol oral solution works in children.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignEndpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Postoperative Pain
  • Acute Pain
InterventionDrug: Tapentadol
Tapentadol oral solution single dose (1mg/kg body weight)
Study Arm (s)Experimental: Tapentadol

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment86
Estimated Completion DateFebruary 2014
Estimated Primary Completion DateFebruary 2014
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 17 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

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%.

- Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis
at enrollment

- Body temperature above 38.5°C within 48 hours prior to dosing
GenderBoth
Ages2 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01729728
Other Study ID NumbersKF5503/68
Has Data Monitoring CommitteeNot Provided
Information Provided ByGrünenthal GmbH
Study SponsorGrünenthal GmbH
CollaboratorsJanssen Research & Development, LLC
Investigators Study Director: Study Director Grünenthal GmbH
Verification DateMarch 2014

Locations[ + expand ][ + ]

Jean Brown Research
Salt Lake City, Utah, United States, 84124