Moderate to Severe Acute Postoperative PainPhase 2NCT02221674
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
A Phase 2 study testing Tapentadol in people with Moderate to Severe Acute Postoperative Pain, run by Grünenthal GmbH at 7 sites in 3 countries.
Trial summary
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to… Read more about this study
- Who is it for?
- Ages 1 day to 23 months
- Conditions the study is for
- Moderate to Severe Acute Postoperative Pain
- What is being tested?
- Tapentadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 5 Nov 2014to 3 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant's parent(s) or legal guardian(s) have given written informed consent to participate.
- Participant is not obese (e.g., a body weight above the 97th percentile for children based on the World Health Organization weight charts) with a minimum body weight of 2.5 kg.
- Physical status rated not higher than P3 on the American Society of Anesthesiologists physical status classification in participants aged from 1 month to less than 2 years.
- Participant has undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment.
- At the time of allocation to IMP, participant has a sedation score that is not higher than 2 (moderately sedated) on the University of Michigan Sedation Scale with the exception of participants who are mechanically ventilated in age subgroup 3, has a functioning gastrointestinal tract after surgery, and can tolerate medication administered orally or via a feeding tube at the time of allocation to IMP.
- Participant has a reliable venous vascular access for pharmacokinetic blood sampling.
Who cannot join
- The participant's parent(s) or legal guardian(s) is an employee of the investigator or trial site, with direct involvement in this trial or other trials under the direction of that investigator or trial site, or the participant, or participant's parent(s), or legal guardian(s) is a family member of the employees or the investigator.
- Participant has been previously exposed to tapentadol.
- Participant has received an experimental drug or used an experimental medical device within 28 days before allocation to study medication, or within a period less than 10 times the drug's half-life, whichever is longer.
- Concomitant participation in another interventional clinical trial for the duration of this trial.
- Participant has undergone brain surgery.
- Participant has undergone a surgery that is expected to affect the absorption of tapentadol (e.g., to the gastrointestinal tract).
Show all 41Show fewer
- Participant has a history or current condition of any one of the following:
- Seizure disorder.
- Traumatic or hypoxic brain injury, i.e. brain contusion, stroke, transient ischemic attack, intracranial bleeding or hematoma, brain neoplasm.
- Participant has a history or current condition of any one of the following:
- Moderate to severe renal impairment.
- Moderate to severe hepatic impairment, congestive hepatopathy, or hepatic portosystemic shunting.
- Clinically relevant abnormal pulmonary function or clinically relevant respiratory disease that in the opinion of the investigator would put the participant at risk for developing respiratory depression, unless the participant is mechanically ventilated in age subgroup 3.
- Participant has signs or symptoms of congestive heart failure (e.g., requiring more than minimal inotropic support, an abnormal lactic acid value greater than 2-times upper limit of normal), or hemorrhagic disorder following surgery.
- Minimal inotropic medication is defined as:
- Dopamine less or equal to 5 microgram/kg per minute.
- Epinephrine less or equal to 0.03 microgram/kg per minute (but not both dopamine and epinephrine).
- Milrinone less or equal to 0.5 microgram/kg per minute or less.
- Participant has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, or psychiatric disorder, or a febrile seizure or paralytic ileus) that in the opinion of the investigator may affect or compromise participant's safety during the trial participation.
- Participant has cognitive or developmental impairment such that trial participation may affect or compromise the participant's safety, or the participant's ability to comply with the protocol requirements (as appropriate for the participant's age), in the investigator's judgment. Otherwise, participant's with cognitive or developmental impairment may be enrolled in the trial.
- Participant has a clinically relevant history of hypersensitivity, allergy, or contraindication to tapentadol (or ingredients).
- Participant has:
- Clinically relevant abnormal 12-lead ECG in the investigator's judgment.
- Signs of pre-excitation syndrome.
- Corrected QT (QTcF) interval greater than 460 ms. Participant may be allocated to Investigational Medicinal Product with values greater than 460 ms if, in the investigator's opinion, the value is a consequence of cardiac surgery and is not considered clinically significant.
- Participant has clinically relevant abnormal lab values from a sample obtained postoperatively and prior to allocation to study medication. The following specifications will apply:
- Aspartate transaminase or alanine transaminase is greater than 2.5-times upper limit of normal.
- Total bilirubin is greater than 2-times upper limit of normal and direct bilirubin is greater than 20% of the total bilirubin, and for participants in age subgroup 3, the presence of pathological jaundice in the opinion of the investigator.
- Glomerular filtration rate (calculated according to Schwartz et al. 1984):
- less than 20 mL/min/1.73 m2 for participants less than 1 week old.
- less than 30 mL/min/1.73 m2 for participants 1 week to 8 weeks old.
- less than 50 mL/min/1.73 m2 for participants more than 8 weeks old.
- Other parameters (in the investigator's judgment).
- Signs or symptoms indicative of a systemic infection within 24 hours prior to allocation to study medication.
- Participant has been administered a prohibited medication.
- The mother of a newborn or the breastfeeding mother of a participant was administered a prohibited medication.
- At the time of dosing, in the investigator's judgment, the participant has either of the following:
- Clinically unstable upper or lower airway conditions or respiratory depression (unless the participant is mechanically ventilated in age subgroup 3).
- Clinically unstable systolic or diastolic blood pressure, heart rate, or respiratory rate.
- Participant has a peripheral oxygen saturation (SpO2) <92% for acyanotic participant, or <75% for cyanotic participant, with or without supplemental oxygen via nasal cannula or high flow nasal cannula, at the time of allocation to Investigational Medicinal Product.
- For age subgroup 1 and age subgroup 2, participant requires continuous positive airway pressure or mechanical ventilation, at the time of allocation to Investigational Medicinal Product.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
US006
Durham, North Carolina, 27710
US002
Louisville, Kentucky, 40202
US001
Palo Alto, California, 94305
US004
Philadelphia, Pennsylvania, 19104
About this study
Official title: Open-label Evaluation of the Population Pharmacokinetic Profile, Safety, Tolerability, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children Aged From Birth to Less Than 2 Years
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain.
The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.
Read the detailed description
This clinical trial has 3 phases: enrollment, treatment (15 hours) and follow up.
During the enrolment phase consent and eligibility will be determined. After surgery, the participant will be given routine pain medication as per standard of care in the hospital.
Treatment phase: When the participant has a functioning gastrointestinal tract after surgery, can tolerate medication administered orally or via a feeding tube, meets the inclusion criteria, and does not meet any exclusion criterion, the participant will be allocated to the investigational medicinal product (IMP). Evaluations will be performed over the next 15 hours, including the assessment of the amount of pain. During this time, 2 blood samples will be taken for testing of the amount of tapentadol and its main metabolites in the participant's blood.
A final follow-up visit is planned to take place up to 2 weeks after taking the trial medication.
- Being tested
- Tapentadol
- Keywords
- Post-surgical pain, Opioid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Also called Palexia®, Nucynta®, Yantil®
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Experimental | Tapentadol 4 mg/mL immediate release oral solution, single dose post-operatively. Receives: Drug: Tapentadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP administration
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP administration
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).
If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Measured: Up to 8 hours after IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study start5 Nov 2014
- Primary completion14 Oct 2016
- Study completion3 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Acute Postoperative PainStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Depomed
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221674
- Sponsor's protocol ID
- KF5503-72
- Other IDs
- 2014-000623-24, U1111-1153-1662, R331333PAI2007, 2014
- Status last verified
- Jan 2018
- First submitted
- 19 Aug 2014
- Last updated
- 29 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Evaluation of the Population Pharmacokinetic Profile, Safety, Tolerability, and Efficacy of Tapentadol Oral Solution for the Treatment of Post-surgical Pain in Children Aged From Birth to Less Than 2 Years
- ClinicalTrials.gov ID
- NCT02221674
- Acronym / sponsor ID
- KF5503-72
- Keywords
- Post-surgical pain, Opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Depomed
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 3 Nov 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain.
The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.
Detailed description
This clinical trial has 3 phases: enrollment, treatment (15 hours) and follow up.
During the enrolment phase consent and eligibility will be determined. After surgery, the participant will be given routine pain medication as per standard of care in the hospital.
Treatment phase: When the participant has a functioning gastrointestinal tract after surgery, can tolerate medication administered orally or via a feeding tube, meets the inclusion criteria, and does not meet any exclusion criterion, the participant will be allocated to the investigational medicinal product (IMP). Evaluations will be performed over the next 15 hours, including the assessment of the amount of pain. During this time, 2 blood samples will be taken for testing of the amount of tapentadol and its main metabolites in the participant's blood.
A final follow-up visit is planned to take place up to 2 weeks after taking the trial medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: TapentadolTapentadol 4 mg/mL immediate release oral solution, single dose post-operatively. |
Who may qualify
- Ages
- 1 day to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The participant's parent(s) or legal guardian(s) have given written informed consent to participate.
- Participant is not obese (e.g., a body weight above the 97th percentile for children based on the World Health Organization weight charts) with a minimum body weight of 2.5 kg.
- Physical status rated not higher than P3 on the American Society of Anesthesiologists physical status classification in participants aged from 1 month to less than 2 years.
- Participant has undergone surgery that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment.
- At the time of allocation to IMP, participant has a sedation score that is not higher than 2 (moderately sedated) on the University of Michigan Sedation Scale with the exception of participants who are mechanically ventilated in age subgroup 3, has a functioning gastrointestinal tract after surgery, and can tolerate medication administered orally or via a feeding tube at the time of allocation to IMP.
Key exclusion criteria (41 listed)
- The participant's parent(s) or legal guardian(s) is an employee of the investigator or trial site, with direct involvement in this trial or other trials under the direction of that investigator or trial site, or the participant, or participant's parent(s), or legal guardian(s) is a family member of the employees or the investigator.
- Participant has been previously exposed to tapentadol.
- Participant has received an experimental drug or used an experimental medical device within 28 days before allocation to study medication, or within a period less than 10 times the drug's half-life, whichever is longer.
- Concomitant participation in another interventional clinical trial for the duration of this trial.
- Participant has undergone brain surgery.
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 |
|---|---|---|
| TapentadolAlso: Palexia®, Nucynta®, Yantil® | Drug | Tapentadol |
Primary outcome
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years
Time frame: Up to 8 hours after IMP administration
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months
Time frame: Up to 8 hours after IMP administration
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month
Time frame: Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years
Time frame: Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months
Time frame: Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month
Time frame: Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated. Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ). If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
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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.
Clinical Trial Director study director
Grünenthal GmbH
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tapentadol in people with Moderate to Severe Acute Postoperative Pain, run by Grünenthal GmbH at 7 sites in 3 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 6 inclusion and 41 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: stopped early, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Poland, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years (time frame: Up to 8 hours after IMP administration). The study lists 6 primary outcomes in all. 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 29 Jan 2018.