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A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tapentadol oral solution 4 mg/mL

Tapentadol oral solution 20 mg/mL

Placebo

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Acute Pain, Post-operative, Tapentadol, Opioid Treatment, Pediatric Participants

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent, and if applicable assent, given according to local regulations.
Male or female participant aged from birth (at least 37 weeks gestational age) to less than 18 years.
A female participant must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female participant is sexually active, then she must be practicing an effective method of birth control (e.g., prescription hormonal contraceptives, intra-uterine devices used according to the product's instruction, double-barrier methods) before trial entry and throughout the trial.
A female participant must have a negative pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active.
Participant has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator's judgment]) that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after first dose of IMP. Participants must remain hospitalized until the End of Treatment Visit.
Participant has received post-operative morphine or hydromorphone by NCA/PCA, with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and participant is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP.
Participant is able to tolerate liquids at the time of allocation/randomization to IMP.

Exclusion Criteria:

Participant, parent or the legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or 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/randomization to IMP, or within a period less than 10 times the drug's half-life, whichever is longer.
Participant has a history or current condition of any one of the following:
- Non-febrile seizure disorder.
- Epilepsy.
- Serotonin syndrome.
- Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, post-traumatic amnesia, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours.
Participant has a history or current condition of any one of the following:
- Moderate to severe renal or hepatic impairment.
- Abnormal pulmonary function or clinically relevant respiratory disease (e.g., acute or severe bronchial asthma, hypercapnia).
Participant has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise participant safety during the study participation.
Participant has history of suicidal ideation or behavior.
Participant is obese in the investigator's judgment. Obesity can be determined based on appropriate body mass index (BMI) charts or tables; e.g., a BMI above the 97th percentile for children based on the World Health Organization growth charts or the participant's weight is less than 2500 grams.
Participant has a clinically relevant history of hypersensitivity, allergy, or contraindication to the supplemental opioid analgesic medication or tapentadol, or the excipients, or naloxone.
Participant is not able to understand and comply with the protocol as appropriate for the age of the participant or participant is cognitively impaired in the investigator's judgment such that they cannot comply with the protocol
Participant has a history of alcohol and/or substance abuse in the investigator's judgment based on participant's history and physical examination.
Participant is taking prohibited concomitant medication.
Participant has received a long-acting opioid for the treatment of pain following surgery within 6 hours of allocation/randomization to IMP.
Participant has clinically relevant (in the investigator's judgment) abnormal values for clinical chemistry or hematology (local laboratory sample taken after surgery).
A participant aged 6 months to less than 18 years old is excluded if the:
- Aspartate transaminase or alanine transaminase is greater 3-times upper limit of normal.
- Total bilirubin is greater 2-times upper limit of normal (except if the cause is due to Gilbert's syndrome).
- Glomerular filtration rate less than 60 mL/min.
A participant aged from birth to less than 6 months old is excluded if:
- Aspartate transaminase or alanine transaminase is >3-times upper limit of normal.
- There is pathological jaundice in the opinion of the investigator.
- Glomerular filtration rate (calculated according to Schwartz et al. 1984) is:
  - <20 mL/min/1.73 m2 for participants <1 week post-partum.
  - <30 mL/min/1.73 m2 for participants 1 week to 8 weeks post-partum.
  - <50 mL/min/1.73 m2 for participants >8 weeks postpartum to <6 months old.
Participant has:
- Clinically relevant abnormal electrocardiogram (ECG).
- Signs of pre-excitation syndrome.
- Brugada's syndrome.
- QT or corrected QT interval (QTc) interval >470 ms for children aged 6 years to less than 18 years old.
- QT or QTc interval >460 ms for children aged from birth to less than 6 years old.
Peri- or post-operative analgesia supplied by a continuous regional technique (e.g., nerve block, wound infiltration catheter) or participant-controlled epidural analgesia that was terminated less than 6 hours before allocation/randomization to IMP.
Participant has post-operative clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions (in the investigator's judgment), or a saturation of peripheral oxygen (SpO2) <92% at the time of randomization (allocation/randomization to IMP).
Female participant is breast-feeding a child.
Participant requires continuous positive airway pressure or mechanical ventilation, at the time of allocation to IMP.
The mother of a newborn participant or the breastfeeding mother of a participant was administered a prohibited medication.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tapentadol immediate-release (IR)

Placebo

Arm Description

In the first 24 hours, tapentadol oral solution at a dose of 1.25 mg/kg body weight was given every 4 hours (±15 min) to participants aged 6 months to less than 18 years (maximum individual dose of tapentadol was 100 mg). Participants from 30 days to less than 6 months were dosed with 0.5 mg/kg body weight every 4 hours. Participants from birth to less than 30 days of age were dosed with 0.1 mg/kg body weight every 4 hours. After 24 hours and up to 72 hours, the dose could be reduced based on the investigator's judgment.

Matching placebo oral solution was administered every 4 hours (±15 min) up to 72 hours.

Outcomes

Primary Outcome Measures

For the US FDA: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 12 Hours After First Intake of Investigational Medicinal Product (IMP) [Tapentadol Oral Solution or Placebo]

The primary endpoint for the United States Food and Drug Administration (US FDA) (and secondary endpoint for the Pediatric Committee of the European Medicines Agency [EU PDCO]) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to <18 years old) within 12 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.

For the EU PDCO: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 24 Hours After First Intake of IMP [Tapentadol Oral Solution or Placebo]

The primary endpoint for the EU PDCO (and secondary endpoint for the US FDA) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to <18 years old) within 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.

Secondary Outcome Measures

Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP

The total amount of supplemental opioid analgesic medication (SOAM) received was assessed in 12-hour intervals from 24 hours to 96 hours after the first dose of IMP for participants who were administered SOAM. SOAM use was expressed in mg/kg of morphine i.v. equivalents.

Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale

Palatability of IMP after the first dose was assessed in participants aged 2 years to less than 18 years using 5-point hedonic scales in combination with verbal rating. A question "How does the medication taste" was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range where 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed. Palatability data was not collected for participants <2 years old.

Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale

Acceptability of IMP in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question "Swallowing the medication is..." was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range, with 5 = really easy, 4 = easy, 3 = a bit easy/a bit difficult, 2 = difficult, and 1 = really difficult. Higher scores represent better acceptability. Responses were summarized. Missing values were not imputed. Acceptability data was not collected in participants <2 years old.

Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years

The FLACC scale was used for children from birth to less than 6 years, or in older children who were not able to report their pain using the other scales. This tool includes 5 categories of pain behaviors: facial expression (F), leg movement (L), activity (A), cry (C), and consolability (C). Each of the 5 categories is scored 0, 1 or 2. The total score between 0 and 10 is the sum of the 5 individual categories. Higher scores represent worse condition. The Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible, up to end of treatment (96 hours). Changes from baseline values were summarized descriptively for each time point.

Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years

For children aged 6 years (if possible) to less than 12 years, pain intensity was assessed by the use of the Faces Pain Scale-Revised (FPS-R). The FPS-R is a validated self-reported 6-point scale (0, 2, 4, 6, 8, 10) with 0 representing no pain and 10 representing very much pain. Facial representations were used to indicate how much the pain hurts. Higher scores represent worse condition. Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible. Changes from baseline pain values were summarized descriptively for each time point up to end of treatment (96 hours).

Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years

For children and adolescents aged 12 years to less than 18 years, pain intensity was assessed by the use of a Visual analog scale (VAS). The participant was asked to draw a single line to indicate the current level of pain intensity on a 100 mm long scale by marking a point on the line in response to: "My pain right now is". The mark was scored between "no pain" and "pain as bad as it could be". A value of 0 indicates "no pain". A value of 100 indicates "pain as bad as it could be". Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible. Changes from baseline values were summarized descriptively for each time point.

Clinical Global Impression of Change (CGIC)

The CGIC was assessed at the End of Treatment Visit (Day 4). The investigator rated the participant's global improvement and satisfaction with the treatment on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. Results were summarized descriptively.

Patient Global Impression of Change (PGIC)

The PGIC was assessed at the End of Treatment Visit (Day 4). Participants rated their impression of overall status on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. If participants were not capable of completing the questionnaire, the parent/legal guardian could completed the questionnaire on behalf of the participant. Results were summarized descriptively.

Time to Receive First and Second Patient- or Nurse-controlled Analgesia After the First Dose of IMP

The time to first and time to second patient-controlled analgesia (PCA) or nurse-controlled analgesia (NCA) after the first dose of IMP were summarized descriptively using time-to-event methods and are displayed by relevant treatment groups. Participants who completed the End of Treatment Visit (scheduled for 96 hours after first IMP) before their first/second use of NCA/PCA or participants who terminated treatment before their first/second use of NCA/PCA were censored at the End of Treatment Visit. Time-to-event variables are reported using Kaplan-Meier analyses. Therefore, values might remain missing if the survival function does not reach a respective threshold. This is indicated by not applicable (NA).

Time From First Dose of IMP Until Treatment Discontinuation Due to Lack of Efficacy

The distributions of the time from the first dose of IMP to treatment discontinuation due to lack of efficacy were summarized descriptively using time-to-event methods. Participants who reached the maximum duration of treatment (72 hours) were censored at 72 hours after first IMP intake. Participants who discontinued during the Treatment Period for reasons other than lack of efficacy were censored at the time of the decision to discontinue treatment. Due to the low number of participants with events in the age group from 2 to <18 years, the median time and the corresponding confidence interval could not be calculated. The number of participants who discontinued early due to lack of efficacy is presented instead.

Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale

Palatability of IMP after the last dose in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question "How does the medication taste" was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range with 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed. Palatability data was not collected in participants <2 years old.

Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale

Full Information

NCT ID

NCT02081391

First Posted

March 5, 2014

Last Updated

January 15, 2020

Sponsor

Grünenthal GmbH

Collaborators

Depomed

1. Study Identification

Unique Protocol Identification Number

NCT02081391

Brief Title

A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

Official Title

An Evaluation of the Efficacy and Safety of Tapentadol Oral Solution in the Treatment of Post-operative Acute Pain Requiring Opioid Treatment in Pediatric Subjects Aged From Birth to Less Than 18 Years Old

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

February 19, 2015 (Actual)

Primary Completion Date

March 3, 2019 (Actual)

Study Completion Date

March 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grünenthal GmbH

Collaborators

Depomed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would produce moderate to severe pain during opioid treatment.

Detailed Description

The supplemental opioid medication reflecting the standard of care was available as patient- or nurse-controlled intravenous (i.v.) morphine or hydromorphone. This supplemental opioid analgesic medication (SOAM) was given to control pain, as needed, in both the treatment and placebo groups. Children and adolescents 6 months and older were dosed with a dose regimen of 1.25 mg/kg body weight for the first 24 hours of treatment. 24 hours after the start of study medication (and based on clinical judgment), a dose reduction to 1.0 mg/kg was allowed. Participants 30 days to less than 6 months old were dosed with a regimen of 0.5 mg/kg for the first 24 hours of treatment. The dose of IMP could be reduced after 24 hours to 0.3 mg/kg (if there was a reduced need for analgesia according to the investigator's judgment). Participants aged from birth to less than 30 days old were dosed with a regimen of 0.1 mg/kg for the first 24 hours of treatment. The dose of the IMP could be reduced after 24 hours to 0.075 mg/kg (if there was a reduced need for analgesia according to the investigator's judgment). The decision to maintain or alter the dose based on the effectiveness of the analgesia (pain killer) and the adverse event profile observed in each participant over the first 24-hour dosing period was made based on the investigator's judgment. In exceptional cases, if a participant had unbearable pain despite using nurse-controlled analgesia (NCA) or patient-controlled analgesia (PCA), an additional bolus (defined as a clinician bolus) of morphine or hydromorphone could have been administered. The clinician bolus could have been given either using the NCA/PCA pump system or by an intravenous bolus injection. The opioid given as a clinician bolus or if the NCA/PCA intravenous line failed, had to be the same opioid used in the NCA/PCA pump system. Dosing with IMP was stopped if: A switch to exclusively oral opioid analgesic medication was indicated according to the local standard of care. Opioid analgesic medication was no longer needed. IMP had been administered for 72 hours. Safety evaluations included assessment of adverse events, physical examination, vital signs, laboratory parameters, electrocardiogram, oxygen saturation, and, only for children older than 6 years of age, a scale to assess suicidal ideation (Columbia Suicide Severity Rating Scale [C-SSRS]). The maximum study duration for each participant was 42 days. The evaluation of the safety and efficacy data was performed by age groups as aligned with European and United States agencies. Within the tapentadol treatment group, no analysis by tapentadol dose was conducted. Results for participants aged 2 years to <18 years were provided to the Pediatric Committee of the European Medicines Agency (EU PDCO) before recruitment of the children less than 6-month old required for the US Food and Drug Administration [FDA] analysis was completed. Participants from birth to <2 years old were analyzed separately for the US FDA only and not included in the analysis of the population aged from 2 years to <18 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

Keywords

Acute Pain, Post-operative, Tapentadol, Opioid Treatment, Pediatric Participants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The trial was double-blinded to prevent bias. The blind was broken for the participants aged 2 years to <18 years (Pediatric Committee of the European Medicines Agency [EU PDCO] set) before recruitment of the <6 month-old subjects for the United Sates Food and Drug Administration (US FDA) set (which comprised participants from birth to <18 years) was completed. Participants not belonging to the EU PDCO set (<2 years old) remained blinded (as independent randomization lists were used for participants aged <2 years old) and were unblinded only after the data base was locked for all participants from birth to <2 years old who were included in the US FDA <2 years population.

Allocation

Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tapentadol immediate-release (IR)

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo oral solution was administered every 4 hours (±15 min) up to 72 hours.

Intervention Type

Drug

Intervention Name(s)

Tapentadol oral solution 4 mg/mL

Intervention Description

Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours. Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold.

Intervention Type

Drug

Intervention Name(s)

Tapentadol oral solution 20 mg/mL

Intervention Description

Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours.

Primary Outcome Measure Information:

Title

Description

Time Frame

Up to 12 hours

Title

For the EU PDCO: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 24 Hours After First Intake of IMP [Tapentadol Oral Solution or Placebo]

Description

Time Frame

Up to 24 hours

Secondary Outcome Measure Information:

Title

Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP

Description

Time Frame

Up to 96 hours

Title

Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale

Description

Time Frame

Up to 96 hours

Title

Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale

Description

Time Frame

Up to 96 hours

Title

Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years

Description

Time Frame

Up to 96 hours

Title

Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years

Description

Time Frame

Up to 96 hours

Title

Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years

Description

Time Frame

Up to 96 hours

Title

Clinical Global Impression of Change (CGIC)

Description

Time Frame

Day 4

Title

Patient Global Impression of Change (PGIC)

Description

Time Frame

Day 4

Title

Time to Receive First and Second Patient- or Nurse-controlled Analgesia After the First Dose of IMP

Description

Time Frame

Up to 96 hours

Title

Time From First Dose of IMP Until Treatment Discontinuation Due to Lack of Efficacy

Description

Time Frame

Up to 72 hours

Title

Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale

Description

Time Frame

Up to 96 hours

Title

Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale

Description

Time Frame

Up to 96 hours

Other Pre-specified Outcome Measures:

Title

Mean Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years

Description

The mean amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.

Time Frame

Up to 24 hours

Title

Median Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years

Description

The median amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.

Time Frame

Up to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent, and if applicable assent, given according to local regulations. Male or female participant aged from birth (at least 37 weeks gestational age) to less than 18 years. A female participant must be pre-menarchal, or surgically incapable of childbearing, or sexually abstinent, or if a female participant is sexually active, then she must be practicing an effective method of birth control (e.g., prescription hormonal contraceptives, intra-uterine devices used according to the product's instruction, double-barrier methods) before trial entry and throughout the trial. A female participant must have a negative pregnancy test if aged 12 years or older, or is post-menarchal, or is sexually active. Participant has undergone surgery (other than brain surgery or gastrointestinal surgery expected to affect the absorption of tapentadol [in the investigator's judgment]) that, in the investigator's opinion, would reliably produce moderate to severe pain requiring opioid treatment for at least 24 hours after first dose of IMP. Participants must remain hospitalized until the End of Treatment Visit. Participant has received post-operative morphine or hydromorphone by NCA/PCA, with or without a background infusion of the same opioid, according to standard of care prior to allocation/randomization to IMP and participant is expected to require this morphine or hydromorphone by NCA/PCA after starting IMP. Participant is able to tolerate liquids at the time of allocation/randomization to IMP. Exclusion Criteria: Participant, parent or the legal representative is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or 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/randomization to IMP, or within a period less than 10 times the drug's half-life, whichever is longer. Participant has a history or current condition of any one of the following: Non-febrile seizure disorder. Epilepsy. Serotonin syndrome. Traumatic or hypoxic brain injury, brain contusion, stroke, transient ischemic attack, intracranial hematoma, post-traumatic amnesia, brain neoplasm, or episode(s) of unconsciousness of more than 24 hours. Participant has a history or current condition of any one of the following: Moderate to severe renal or hepatic impairment. Abnormal pulmonary function or clinically relevant respiratory disease (e.g., acute or severe bronchial asthma, hypercapnia). Participant has a concomitant disease or disorder (e.g., endocrine, metabolic, neurological, psychiatric, infection, febrile seizure, paralytic ileus) that in the opinion of the investigator may affect or compromise participant safety during the study participation. Participant has history of suicidal ideation or behavior. Participant is obese in the investigator's judgment. Obesity can be determined based on appropriate body mass index (BMI) charts or tables; e.g., a BMI above the 97th percentile for children based on the World Health Organization growth charts or the participant's weight is less than 2500 grams. Participant has a clinically relevant history of hypersensitivity, allergy, or contraindication to the supplemental opioid analgesic medication or tapentadol, or the excipients, or naloxone. Participant is not able to understand and comply with the protocol as appropriate for the age of the participant or participant is cognitively impaired in the investigator's judgment such that they cannot comply with the protocol Participant has a history of alcohol and/or substance abuse in the investigator's judgment based on participant's history and physical examination. Participant is taking prohibited concomitant medication. Participant has received a long-acting opioid for the treatment of pain following surgery within 6 hours of allocation/randomization to IMP. Participant has clinically relevant (in the investigator's judgment) abnormal values for clinical chemistry or hematology (local laboratory sample taken after surgery). A participant aged 6 months to less than 18 years old is excluded if the: Aspartate transaminase or alanine transaminase is greater 3-times upper limit of normal. Total bilirubin is greater 2-times upper limit of normal (except if the cause is due to Gilbert's syndrome). Glomerular filtration rate less than 60 mL/min. A participant aged from birth to less than 6 months old is excluded if: Aspartate transaminase or alanine transaminase is >3-times upper limit of normal. There is pathological jaundice in the opinion of the investigator. Glomerular filtration rate (calculated according to Schwartz et al. 1984) is: <20 mL/min/1.73 m2 for participants <1 week post-partum. <30 mL/min/1.73 m2 for participants 1 week to 8 weeks post-partum. <50 mL/min/1.73 m2 for participants >8 weeks postpartum to <6 months old. Participant has: Clinically relevant abnormal electrocardiogram (ECG). Signs of pre-excitation syndrome. Brugada's syndrome. QT or corrected QT interval (QTc) interval >470 ms for children aged 6 years to less than 18 years old. QT or QTc interval >460 ms for children aged from birth to less than 6 years old. Peri- or post-operative analgesia supplied by a continuous regional technique (e.g., nerve block, wound infiltration catheter) or participant-controlled epidural analgesia that was terminated less than 6 hours before allocation/randomization to IMP. Participant has post-operative clinically unstable systolic and diastolic blood pressure, heart rate, respiratory depression, or clinically unstable upper or lower airway conditions (in the investigator's judgment), or a saturation of peripheral oxygen (SpO2) <92% at the time of randomization (allocation/randomization to IMP). Female participant is breast-feeding a child. Participant requires continuous positive airway pressure or mechanical ventilation, at the time of allocation to IMP. The mother of a newborn participant or the breastfeeding mother of a participant was administered a prohibited medication.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grünenthal Study Director

Organizational Affiliation

Grünenthal GmbH

Official's Role

Study Director

Facility Information:

Facility Name

US008

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

US004

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

US011

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

US012

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

US001

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

US018

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

US006

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

US016

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

US015

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

US014

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

US003

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

US005

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

US007

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

BG003

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

BG005

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

BG002

City

Stara Zagora

ZIP/Postal Code

600

Country

Bulgaria

Facility Name

HR003

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

HR001

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

CZ004

City

Karviná

ZIP/Postal Code

73506

Country

Czechia

Facility Name

CZ003

City

Olomouc

ZIP/Postal Code

77900

Country

Czechia

Facility Name

CZ001

City

Praha 4 - Krč

ZIP/Postal Code

14059

Country

Czechia

Facility Name

FR002

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

FR001

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

FR004

City

Limoges

ZIP/Postal Code

87000

Country

France

Facility Name

DE001

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

HU004

City

Budapest

ZIP/Postal Code

1094

Country

Hungary

Facility Name

HU003

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

PL011

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

PL010

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

PL005

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

PL002

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

PL009

City

Olsztyn

ZIP/Postal Code

10-561

Country

Poland

Facility Name

PL014

City

Rzeszow

ZIP/Postal Code

35-301

Country

Poland

Facility Name

PL007

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

PL004

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

PL008

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

ES002

City

Barcelona

ZIP/Postal Code

8950

Country

Spain

Facility Name

ES005

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

ES007

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

ES009

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

ES006

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

GB003

City

Bristol

ZIP/Postal Code

BS2 8BJ

Country

United Kingdom

Facility Name

GB001

City

Sheffield

ZIP/Postal Code

S10 2TH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Information available on the Grünenthal Web Site

IPD Sharing URL

http://www.grunenthal.com/r-d-vision-mission/clinical-trials/data-sharing-clinical-trials

Citations:

PubMed Identifier

6726515

Citation

Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatr. 1984 Jun;104(6):849-54. doi: 10.1016/s0022-3476(84)80479-5.

Results Reference

background

Learn more about this trial

A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

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A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain

Acute Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial