Trial Outcomes & Findings for Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old (NCT NCT02221674)

Last Updated: 2018-01-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 8 hours after IMP administration

Results posted on

2018-01-29

Participant Flow

The first patient signed the informed consent on 05 Nov 2014. The last patient completed the trial on 03 Nov 2016. The trial followed a staggered recruitment by age, starting with the recruitment of patients in the oldest age group. Exposure and safety of at least 2 patients has been assessed before opening enrollment in the next younger age group.

Consent was obtained for 40 participants in the trial. 19 participants were allocated and received study drug (investigational medicinal product). Pharmacokinetic data was obtained for 18 participants. 21 patients were enrolled but not allocated.

Participant milestones

Participant milestones
Measure	Participants Aged 6 Months to Less Than 2 Years Infants aged 6 months to less than 2 years at the time of allocation to IMP (investigational medicinal product). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg.	Participants Aged 1 Month to Less Than 6 Months Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
Overall Study STARTED	8	6	5
Overall Study COMPLETED	7	6	5
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Aged 6 Months to Less Than 2 Years Infants aged 6 months to less than 2 years at the time of allocation to IMP (investigational medicinal product). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg.	Participants Aged 1 Month to Less Than 6 Months Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Aged 6 Months to Less Than 2 Years n=8 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg.	Participants Aged 1 Month to Less Than 6 Months n=6 Participants Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month n=5 Participants Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	420.0 days STANDARD_DEVIATION 147.8 • n=5 Participants	92.8 days STANDARD_DEVIATION 37.9 • n=7 Participants	14.6 days STANDARD_DEVIATION 8.5 • n=5 Participants	210.0 days STANDARD_DEVIATION 209.0 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	15 participants n=4 Participants
Region of Enrollment Poland	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Height	73.3 centimeter STANDARD_DEVIATION 5.2 • n=5 Participants	62.0 centimeter STANDARD_DEVIATION 4.3 • n=7 Participants	53.4 centimeter STANDARD_DEVIATION 4.4 • n=5 Participants	64.5 centimeter STANDARD_DEVIATION 9.5 • n=4 Participants
Weight	9.21 kilogram STANDARD_DEVIATION 1.50 • n=5 Participants	5.92 kilogram STANDARD_DEVIATION 1.18 • n=7 Participants	3.78 kilogram STANDARD_DEVIATION 0.66 • n=5 Participants	6.74 kilogram STANDARD_DEVIATION 2.59 • n=4 Participants
Body Mass Index (BMI)	17.11 kilogram per square meter STANDARD_DEVIATION 1.36 • n=5 Participants	15.28 kilogram per square meter STANDARD_DEVIATION 1.31 • n=7 Participants	13.36 kilogram per square meter STANDARD_DEVIATION 2.49 • n=5 Participants	15.55 kilogram per square meter STANDARD_DEVIATION 2.24 • n=4 Participants
Baseline Pain Intensity using the FLACC Scale	2.8 units on a scale STANDARD_DEVIATION 2.9 • n=5 Participants	3.8 units on a scale STANDARD_DEVIATION 3.9 • n=7 Participants	1.6 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 3.0 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 8 hours after IMP administration

Population: The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=7 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	9.8 nanogram per milliliter Standard Deviation 5.21	—	—
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 1 hour after administration	18.79 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	32.2 nanogram per milliliter Standard Deviation 14.92	—	—
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 4 hours after administration	11.1 nanogram per milliliter Standard Deviation 5.97	—	—
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 6 hours after administration	14.85 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	10.7 nanogram per milliliter Standard Deviation 4.15	—	—

PRIMARY outcome

Timeframe: Up to 8 hours after IMP administration

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=6 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	8.3 nanogram per milliliter Standard Deviation 6.30	—	—
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 1 hour after administration	35.27 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	27.3 nanogram per milliliter Standard Deviation 0.81	—	—
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 4 hours after administration	25.9 nanogram per milliliter Standard Deviation 10.33	—	—
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 6 hours after administration	32.75 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	5.6 nanogram per milliliter Standard Deviation 1.81	—	—

PRIMARY outcome

Timeframe: Up to 8 hours after IMP

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=5 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	26.62 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 1 hour after administration	43.63 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	19.9 nanogram per milliliter Standard Deviation 7.67	—	—
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 4 hours after administration	15.0 nanogram per milliliter Standard Deviation 8.92	—	—
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 6 hours after administration	18.82 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	14.6 nanogram per milliliter Standard Deviation 6.26	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=7 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	105.7 nanogram per milliliter Standard Deviation 125.00	—	—
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 1 hour after administration	430.7 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	468.0 nanogram per milliliter Standard Deviation 248.41	—	—
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 4 hours after administration	348.7 nanogram per milliliter Standard Deviation 228.22	—	—
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 6 hours after administration	370.2 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	285.1 nanogram per milliliter Standard Deviation 107.06	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=6 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	128.8 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 1 hour after administration	136.3 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	324.9 nanogram per milliliter Standard Deviation 116.61	—	—
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 4 hours after administration	449.7 nanogram per milliliter Standard Deviation 7.42	—	—
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 6 hours after administration	253.3 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	92.2 nanogram per milliliter Standard Deviation 63.83	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=5 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
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 30 minutes after administration	74.38 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 1 hour after administration	209 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 2 hours after administration	98.5 nanogram per milliliter Standard Deviation 2.62	—	—
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 4 hours after administration	147.6 nanogram per milliliter Standard Deviation 53.74	—	—
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 6 hours after administration	224.8 nanogram per milliliter Standard Deviation NA One sample was used at this specified time point.	—	—
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 8 hours after administration	174.1 nanogram per milliliter Standard Deviation 11.03	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; up to 15 hours after study medication

Population: For the Arm/Group "Participants aged 6 months to less than 2 years" only 7 values were available at the timepoint "6 hours after administration".

The change from baseline in pain intensity using the Face, Legs, Activity, Cry, Consolability Scale (FLACC Scale) at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after a single dose of tapentadol. The FLACC Scale is a behavioral scale for scoring postoperative pain in young children. It includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The scale is scored in a range of 0-10 with 0 representing no pain. The pain intensity scores were summarized descriptively per scheduled time point.

Outcome measures

Outcome measures
Measure	Participants Aged 6 Months to Less Than 2 Years - PK Set n=8 Participants Infants aged 6 months to less than 2 years at the time of allocation to IMP who had quantifiable serum concentrations.	Participants Aged 1 Month to Less Than 6 Months. n=6 Participants Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. n=5 Participants Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 15 minutes after administration	-0.8 units on a scale Standard Deviation 3.1	-1.3 units on a scale Standard Deviation 2.8	-1.6 units on a scale Standard Deviation 1.5
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 30 minutes after administration	-1.1 units on a scale Standard Deviation 2.6	-3.0 units on a scale Standard Deviation 3.6	-1.4 units on a scale Standard Deviation 1.5
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 1 hour after administration	-2.0 units on a scale Standard Deviation 3.6	-2.7 units on a scale Standard Deviation 4.5	0.0 units on a scale Standard Deviation 3.7
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 2 hours after administration	-2.8 units on a scale Standard Deviation 2.9	-3.0 units on a scale Standard Deviation 3.9	-0.4 units on a scale Standard Deviation 2.6
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 4 hours after administration	-1.6 units on a scale Standard Deviation 3.4	-2.2 units on a scale Standard Deviation 3.3	-0.4 units on a scale Standard Deviation 2.3
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 6 hours after administration	-1.9 units on a scale Standard Deviation 3.1	-1.7 units on a scale Standard Deviation 4.8	-0.4 units on a scale Standard Deviation 2.3
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 8 hours after administration	-2.5 units on a scale Standard Deviation 2.5	-3.0 units on a scale Standard Deviation 3.2	-1.2 units on a scale Standard Deviation 1.1
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 12 hours after administration	-2.4 units on a scale Standard Deviation 2.8	-3.5 units on a scale Standard Deviation 3.8	-1.4 units on a scale Standard Deviation 1.5
Change From Baseline (Visit 1, After Surgery) in Pain Intensity 15 hours after administration	-2.1 units on a scale Standard Deviation 3.5	-3.8 units on a scale Standard Deviation 3.9	-1.0 units on a scale Standard Deviation 2.1

Adverse Events

Participants Aged 6 Months to Less Than 2 Years.

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Participants Aged 1 Month to Less Than 6 Months.

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Participants Aged From Birth to Less Than 1 Month.

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants Aged 6 Months to Less Than 2 Years. n=8 participants at risk Infants aged 6 months to less than 2 years at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 6 months to less than 2 years received a dose of 0.75 mg/kg.	Participants Aged 1 Month to Less Than 6 Months. n=6 participants at risk Infants aged 1 month to less than 6 months at the time of allocation to IMP. Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Infants aged 1 month to less than 6 months received a dose of 0.60 mg/kg.	Participants Aged From Birth to Less Than 1 Month. n=5 participants at risk Neonates aged less than 1 month at the time of allocation to IMP (must be ≥37 weeks gestational age). Participants received a single dose of tapentadol oral solution postoperatively. The dose administered depended on the age of the subject and the body weight. Neonates aged less than 1 month received a dose of 0.50 mg/kg.
Cardiac disorders Junctional ectopic tachycardia	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	16.7% 1/6 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	20.0% 1/5 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
General disorders Pyrexia	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	20.0% 1/5 • Number of events 2 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Injury, poisoning and procedural complications Stoma site erythema	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	20.0% 1/5 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	20.0% 1/5 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Investigations Blood creatine phosphokinase increased	12.5% 1/8 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Investigations Blood potassium decreased	12.5% 1/8 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Investigations Oxygen saturation decreased	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	20.0% 1/5 • Number of events 3 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Renal and urinary disorders Renal failure	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	16.7% 1/6 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Respiratory, thoracic and mediastinal disorders Tachypnoea	12.5% 1/8 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/6 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.
Vascular disorders Hypertension	0.00% 0/8 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	16.7% 1/6 • Number of events 1 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.	0.00% 0/5 • Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE. The therapeutic reach is the time after IMP intake that a subject is still considered to be potentially affected by a study drug. For tapentadol oral solution, the therapeutic reach is defined as 48 hours after (last) IMP intake.

Additional Information

Director of Clinical Trials

Grünenthal GmbH

Phone: +49 241 569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
Publication restrictions are in place

Restriction type: OTHER