Pain, PostoperativePhase 2NCT01134536
Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
A Phase 2 study testing Tapentadol (OS) Oral Solution in people with Pain, Postoperative and Postoperative Pain, run by Janssen Research & Development, LLC at 17 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pain, Postoperative, Postoperative Pain
- What is being tested?
- Tapentadol (OS) Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent(s) or the legal guardian(s) of the patient signed an informed consent document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child to participate in the study
- Physical status rated as I or II on the American Society of Anesthesiologists (ASA) rating scale
- Patient is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age)
- As per investigator's medical evaluation, patient is able to drink and tolerate oral fluids and medication
- Patient has a postoperative pain intensity score >=4 on the McGrath Color Analog Scale (CAS) as a result of a scheduled surgical procedure or if in the investigator's clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the patient has a pain level that the standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment
Who cannot join
- History of seizure disorder or epilepsy, or serotonin syndrome, or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or any traumatic or hypoxic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness
- Moderate to severe renal or hepatic impairment
- Requires concomitant use of sedatives, other than those used during surgery
- Has received dextromethorphan within 2 days before the scheduled study drug administration.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States10 sites
Study site
Ann Arbor, Michigan
Study site
Charlotte, North Carolina
Study site
Durham, North Carolina
Study site
Little Rock, Arkansas
Study site
Meridian, Idaho
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Washington D.C., District of Columbia
Canada3 sites
Study site
Hamilton, Ontario
Study site
Ottawa, Ontario
Study site
Sherbrooke, Quebec
About this study
Official title: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
Read the detailed description
This is a multicenter, single-arm, open-label (all people involved know the identity of the intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in children aged from 6 to less than 18 years after scheduled surgical procedures that routinely produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of care but not exceeding 30 days, will include the preoperative evaluation, the surgical procedure and its immediate post recovery, and will be followed by the open-label treatment phase and end-of-study assessments. Study drug administration will take place after the surgery has been completed, when the patient is alert, orientated, able to follow commands and complete the required postoperative procedures, and able to tolerate fluid and medication orally. Confinement to the study center for a patient will be as per standard of care, and will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with a single dose of tapentadol 20 mg/mL OS.
- Conditions
- Pain, Postoperative, Postoperative Pain
- Being tested
- Tapentadol (OS) Oral Solution
- Keywords
- Pain, Postoperative, Postoperative Pain, Tapentadol, NUCYNTA, CG5503, R331333, Pharmacokinetics, Postsurgical pain, Children, Adolescents
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol (OS) Oral SolutionDrug
Tapentadol OS Bodyweight <20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight >=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol Oral Solution (OS) | Experimental | Not described Receives: Drug: Tapentadol (OS) Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile
Measured: 15 hours after the dose
Secondary outcomes (2)
number of patients with adverse events as a measure of safety and tolerability
Measured: end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Number of patients with adverse events as a measure of safety and tolerability
Measured: Up to 15 hours post treatment on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134536
- Sponsor's protocol ID
- CR016891
- Other IDs
- R331333PAI2005, KF59, 2010-020380-20, KF5503/59
- Status last verified
- Jul 2014
- First submitted
- 28 May 2010
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
- ClinicalTrials.gov ID
- NCT01134536
- Acronym / sponsor ID
- CR016891
- Conditions
- Pain, Postoperative, Postoperative Pain
- Keywords
- Pain, Postoperative, Postoperative Pain, Tapentadol, NUCYNTA, CG5503, R331333, Pharmacokinetics, Postsurgical pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
Detailed description
This is a multicenter, single-arm, open-label (all people involved know the identity of the intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in children aged from 6 to less than 18 years after scheduled surgical procedures that routinely produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of care but not exceeding 30 days, will include the preoperative evaluation, the surgical procedure and its immediate post recovery, and will be followed by the open-label treatment phase and end-of-study assessments. Study drug administration will take place after the surgery has been completed, when the patient is alert, orientated, able to follow commands and complete the required postoperative procedures, and able to tolerate fluid and medication orally. Confinement to the study center for a patient will be as per standard of care, and will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with a single dose of tapentadol 20 mg/mL OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tapentadol Oral Solution (OS) | Experimental | Drug: Tapentadol (OS) Oral Solution |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent(s) or the legal guardian(s) of the patient signed an informed consent document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child to participate in the study
- Physical status rated as I or II on the American Society of Anesthesiologists (ASA) rating scale
- Patient is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age)
- As per investigator's medical evaluation, patient is able to drink and tolerate oral fluids and medication
- Patient has a postoperative pain intensity score >=4 on the McGrath Color Analog Scale (CAS) as a result of a scheduled surgical procedure or if in the investigator's clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the patient has a pain level that the standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment
Key exclusion criteria (4 listed)
- History of seizure disorder or epilepsy, or serotonin syndrome, or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or any traumatic or hypoxic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness
- Moderate to severe renal or hepatic impairment
- Requires concomitant use of sedatives, other than those used during surgery
- Has received dextromethorphan within 2 days before the scheduled study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapentadol (OS) Oral SolutionTapentadol OS Bodyweight <20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight >=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once. | Drug | Tapentadol Oral Solution (OS) |
Primary outcome
Pharmacokinetic profile
Time frame: 15 hours after the dose
2 secondary outcomes
number of patients with adverse events as a measure of safety and tolerability
Time frame: end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 15 hours post treatment on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 YearsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC C. Clinical Trial study director
Janssen Research & Development, LLC
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tapentadol (OS) Oral Solution in people with Pain, Postoperative and Postoperative Pain, run by Janssen Research & Development, LLC at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile (time frame: 15 hours after the dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.