Phase 2
Completed N=66
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
Source: ClinicalTrials.gov NCT01729728 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Nov 2014
Primary outcomePrimary: Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years). — 23.2; 45.6; 49.4; 43.1 nanogram per milliliter
Summary
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.
Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years). |
23.2; 45.6; 49.4; 43.1; 32.8; 22.3 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years). |
404; 855; 1424; 1202; 824; 497 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years). |
36.5; 36.5; 13.5; 3.71 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years). |
676; 900; 321; 86.3 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years). |
30.1; 26.4 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years). |
494; 504 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years). |
19.9; 37.7; 23.4; 10.0 | — |
| PRIMARY Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years). |
497; 938; 624; 253 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years). |
302 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years). |
67.5 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years). |
1.4 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years). |
7082 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years). |
1487 | — |
| PRIMARY Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18). |
1.70 | — |
| SECONDARY Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years). |
71.5; 63.6; 53.2; 46.3; 34.0; 43.5 | — |
| SECONDARY Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years). |
6.643; 4.670; 6.131; 3.071; 5.262; 2.571 | — |
| SECONDARY Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years. |
4.8; 6.8; 3.5; 4.5; 2.9; 2.8 | — |
| SECONDARY Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years). |
4.2; 1.8; 1.2; 1.1; 0.8; 1.5 | — |
| SECONDARY Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups |
106.282; 8.925; 9.698; 8.724; 17.646; 11.614 | — |
| SECONDARY Respiratory Rate Assessments |
17.8; 18.4; 25.1; 16.4; 19.2; 25.1 | — |
| SECONDARY Oxygen Saturation Assessments |
97.8; 97.4; 97.4; 97.7; 96.7; 96.8 | — |
| SECONDARY Systolic and Diastolic Blood Pressure Assessments |
110.2; 103.8; 98.7; 122.9; 107.1; 105.1 | — |
| SECONDARY Change From Enrollment in 12-lead Electrocardiogram Parameters |
-3.6; 15.7; 5.6; -8.0; 8.5; -4.1 | — |
| SECONDARY Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter |
2.0; 4.3; 10.7 | — |
| SECONDARY Treatment Emergent Adverse Events by Intensity |
22; 33; 11; 10; 16; 10 | — |
| SECONDARY Intake of Additional Analgesic Medication During the Trial |
12; 18; 15; 3; 3; 8 | — |
| SECONDARY Hematology Safety Laboratory Assessments: Hemoglobin Concentration |
151.10; 140.04; 127.47; 145.67; 128.64; 121.75 | — |
| SECONDARY Hematology Safety Laboratory Assessments: Hematocrit |
0.436; 0.400; 0.368; 0.421; 0.372; 0.363 | — |
| SECONDARY Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume) |
86.1; 82.3; 79.6; 86.5; 83.1; 81.8 | — |
| SECONDARY Hematology Safety Laboratory Assessments: Platelet Count |
297.0; 347.1; 357.4; 266.1; 303.4; 312.6 | — |
| SECONDARY Hematology Safety Laboratory Assessments: Leukocyte Concentration |
6.631; 7.594; 6.555; 8.537; 12.509; 10.751 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration |
4.77; 4.81; 5.01; 5.10; 6.39; 5.89 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration |
140.9; 140.4; 139.3; 140.3; 138.4; 139.1 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration |
4.20; 4.20; 4.09; 3.90; 3.83; 4.04 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration |
2.455; 2.482; 2.519; 2.268; 2.267; 2.343 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration |
103.3; 103.4; 103.8; 106.6; 104.9; 106.2 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration |
1.384; 1.560; 1.689; 1.234; 1.248; 1.412 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration |
4.55; 4.47; 5.15; 4.54; 4.38; 4.19 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Creatinine Concentration |
73.3; 49.5; 35.6; 67.8; 44.1; 31.6 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity |
21.5; 27.9; 33.4; 21.6; 29.9; 37.9 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Triglycerides Concentration |
1.118; 1.129; 1.223; 0.666; 0.499; 0.556 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration |
43.4; 43.4; 42.6; 38.4; 37.1; 38.9 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Urate in the Blood |
301.62; 228.32; 214.82; 305.57; 225.39; 205.65 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate |
133.6; 133.9; 141.5; 146.6; 155.1; 166.9 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Urine Specific Gravity |
1.025; 1.024; 1.021; 1.022; 1.024; 1.024 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test |
6.2; 6.5; 6.2; 6.1; 6.2; 6.4 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity |
16.2; 15.9; 16.4; 14.1; 15.7; 17.9 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity |
12.0; 10.6; 9.4; 10.4; 8.7; 8.6 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration |
12.0; 6.8; 4.8; 10.9; 6.3; 3.7 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity |
157.7; 210.5; 243.8; 154.5; 199.1; 256.3 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Blood Protein Concentration |
72.3; 73.3; 68.6; 64.2; 61.8; 62.1 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity |
126.0; 109.8; 133.4; 186.8; 283.3; 275.8 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity |
124.7; 240.0; 230.1; 114.7; 207.5; 210.2 | — |
| SECONDARY Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity |
29.5; 30.3; 26.3; 22.7; 22.6; 19.6 | — |
Eligibility Criteria
Inclusion Criteria
- A maximum body weight of 85.0 kg.
- A minimum body weight of 10 kg for participants aged 2 years to less than 3 years old.
- If female and post-menarchal, or 12 years or older, the subject has a negative urine pregnancy test within 24 hours before surgery.
- Having completed either dental surgery or tonsillectomy with or without adenoidectomy surgery (age group: 6 to less than 18 years of age).
- Having completed ear, nose, or throat surgery (including but not limited to tonsillectomy (age group: 2 to less than 3 years of age).
- Participant aged 6 to less than 18 years has a post-operative pain intensity score greater than or equal to 4 on the Color Analog Scale (CAS) as a result of the surgical procedure or the participant has a pain level that the usual standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment.
- Participant aged 2 years to less than 6 years has a pain level following a surgical procedure that reliably produces moderate to severe pain, for which the usual standard of care requires opioid treatment.
- Participant is alert, orientated, and able to follow commands and complete the post-operative required procedures.
Exclusion Criteria
- History of brain injury.
- Clinically relevant abnormal ECG.
- Clinically unstable vital signs and/or a saturation of oxygen saturation (SpO2) less than 93%. During surgery SpO2 may decrease <93%.
- Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis at enrollment.
- Body temperature above 38.5°C within 48 hours prior to dosing.
- Positive drugs of abuse test result.
Data sourced from ClinicalTrials.gov (NCT01729728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.