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. |
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Condition | Postoperative Pain Acute Pain |
Intervention | Drug: Tapentadol |
Phase | Phase 2 |
Sponsor | Grünenthal GmbH |
Responsible Party | Grünenthal GmbH |
ClinicalTrials.gov Identifier | NCT01729728 |
First Received | November 6, 2012 |
Last Updated | March 4, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | November 6, 2012 |
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Last Updated Date | March 4, 2014 |
Start Date | November 2012 |
Estimated Primary Completion Date | February 2014 |
Current Primary Outcome Measures | Pharmacokinetic 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain |
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Official Title | 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. |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Tapentadol Tapentadol oral solution single dose (1mg/kg body weight) |
Study Arm (s) | Experimental: Tapentadol |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 86 |
Estimated Completion Date | February 2014 |
Estimated Primary Completion Date | February 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 |
Gender | Both |
Ages | 2 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01729728 |
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Other Study ID Numbers | KF5503/68 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Grünenthal GmbH |
Study Sponsor | Grünenthal GmbH |
Collaborators | Janssen Research & Development, LLC |
Investigators | Study Director: Study Director Grünenthal GmbH |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
Jean Brown Research | Salt Lake City, Utah, United States, 84124 |
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