An Efficacy and Safety Study of Tapentadol in the Treatment of Post-operative Acute Pain Requiring Opiod Treatment in Pediatric Participants
Overview[ - collapse ][ - ]
Purpose | The purpose of the study is to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opiod analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product in children and adolescents who have undergone surgery that would produce moderate to severe pain during opiod treatment. |
---|---|
Condition | Acute Pain |
Intervention | Drug: Tapentadol 4 mg/mL Drug: Tapentadol 20 mg/mL Other: Placebo |
Phase | Phase 3 |
Sponsor | Janssen Research & Development, LLC |
Responsible Party | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier | NCT02081391 |
First Received | March 5, 2014 |
Last Updated | April 9, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 5, 2014 |
---|---|
Last Updated Date | April 9, 2014 |
Start Date | May 2014 |
Estimated Primary Completion Date | July 2016 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | An Efficacy and Safety Study of Tapentadol in the Treatment of Post-operative Acute Pain Requiring Opiod Treatment in Pediatric Participants |
---|---|
Official Title | An Evaluation of the Efficacy and Safety of Tapentadol Oral Solution in the Treatment of Post-operative Acute Pain Requiring Opioid Treatment in Pediatric Subjects Aged From Birth to Less Than 18 Years Old |
Brief Summary | The purpose of the study is to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opiod analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product in children and adolescents who have undergone surgery that would produce moderate to severe pain during opiod treatment. |
Detailed Description | This is a randomized (the study medication is assigned by chance), multi-site, double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), parallel group (each group of participants will be treated at the same time), and multiple oral dose study. This study will consist of an enrollment phase (up to 28 days), a treatment phase (2 days), and a follow-up phase (up to 12 days). A dose regimen of 1.25 mg/kg will be used for the first 24 hours of treatment in this study in children aged 6 years to less than 18 years old. After 24 hours after the start of study medication, and based on clinical judgment, the dose may either be continued at 1.25 mg/kg or it may be decreased to 1.0 mg/kg. A decision to maintain or alter the dose will depend on the effectiveness of the analgesia (pain killer) and the adverse event profile observed in each child over the first 24 hour dosing period. The doses for participants aged less than 6 years old will be defined based on the forthcoming pharmacokinetic (what the body does to a medication) data. The rescue medication will be available as patient or nurse controlled intravenous morphine or hydromorphone. This rescue medication will be given to control pain, as needed, in both the treatment and placebo groups. Safety evaluations will include assessment of adverse events, vital signs, laboratory parameters, electrocardiogram, and specific scale to assess suicidal ideation. The maximum study duration for each participant will be 42 days. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Acute Pain |
Intervention | Drug: Tapentadol 4 mg/mL Participants aged from 6 years to less than 18 years with body weight less than 20 kg will receive 1.25 mg/kg of tapentadol 4 mg/mL solution orally (by mouth) every 4 hours during the first 24 hours and 1.25 mg/kg or 1.0 mg/kg during the second 24 hours for 2 days. Dose of tapentadol 4 mg/mL solution for participants aged birth to less than 6 years with body weight less than 20 kg will be decided based on the forthcoming pharmacokinetic (PK) [what the body does to a medication] data. Drug: Tapentadol 20 mg/mL Participants aged from 6 years to less than 18 years with body weight greater than or equal to 20 kg will receive 1.25 mg/kg of tapentadol 20 mg/mL solution orally every 4 hours during the first 24 hours and 1.25 mg/kg or 1.0 mg/kg during the second 24 hours for 2 days. Dose of tapentadol 20 mg/mL solution for participants aged birth to less than 6 years with body weight greater than or equal to 20 kg will be decided based on the forthcoming PK data. Other: Placebo Matching placebo solution will be administered orally every 4 hours during the first 24 hours and second 24 hours for 2 days.. |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
---|---|
Estimated Enrollment | 200 |
Estimated Completion Date | July 2016 |
Estimated Primary Completion Date | July 2016 |
Eligibility Criteria | Inclusion Criteria: - A female participant must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female participant is sexually active, then she must be practicing an effective method of birth control (eg, prescription hormonal contraceptives, intra-uterine devices used according to the product's instruction, double-barrier methods) before study entry and throughout the study - A female participant must have a negative urine pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active - Participant has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator's judgment]) that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after allocation/randomization to investigational medicinal product (IMP) [a term used to describe the preparations under investigation in this study, ie, tapentadol oral solution and placebo] - Participant has received post-operative morphine or hydromorphone by nurse controlled analgesia (NCA)/patient controlled analgesia (PCA), with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and participant is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP - Participant is able to tolerate liquids at the time of allocation/randomization to IMP Exclusion Criteria: - Participant has been previously exposed to tapentadol - Participant has received an experimental drug or used an experimental medical device within 28 days before allocation/randomization to IMP, or within a period less than 10 times the drug's half-life, whichever is longer - Participant has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise participant safety during the study participation - Participant has history of suicidal ideation or behavior - Participant has a history of alcohol and/or substance abuse in the investigator's judgment based on participant's history and physical examination |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email JNJ.CT@sylogent.com |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02081391 |
---|---|
Other Study ID Numbers | CR100949 |
Has Data Monitoring Committee | Yes |
Information Provided By | Janssen Research & Development, LLC |
Study Sponsor | Janssen Research & Development, LLC |
Collaborators | Grünenthal GmbH |
Investigators | Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC |
Verification Date | April 2014 |