Trial Outcomes & Findings for Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects (NCT NCT01959204)

NCT ID: NCT01959204

Last Updated: 2023-01-11

Results Overview

Cmax of Oxycodone over a 24 hour period.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 97 participants
• Primary outcome timeframe: 5, 15, 30, and 60 minutes post dose; and 2, 4, 6, 8, 12, and 24 hours post-dose.
• Results posted on: 2023-01-11

Participant Flow

Participant milestones

Measure	Oxycodone Oral Solution Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Overall Study STARTED	97
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Oxycodone Oral Solution n=97 Participants Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Age, Categorical <=18 years	97 Participants n=97 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=97 Participants
Age, Categorical >=65 years	0 Participants n=97 Participants
Sex: Female, Male Female	45 Participants n=97 Participants
Sex: Female, Male Male	52 Participants n=97 Participants
Region of Enrollment United States	97 Participants n=97 Participants

PRIMARY outcome

Timeframe: 5, 15, 30, and 60 minutes post dose; and 2, 4, 6, 8, 12, and 24 hours post-dose.

Cmax of Oxycodone over a 24 hour period.

Outcome measures

Measure	Active n=89 Participants Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Cmax of Oxycodone Oral Solution.	5.92 mg/kg Standard Deviation .53

SECONDARY outcome

Timeframe: 48 hours

Patients will be monitored for adverse events such as change in blood pressure and lack of efficacy.

Outcome measures

Measure	Active n=97 Participants Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Number of Participants With Adverse Events	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5, 15, 30, and 60 minutes post-dose; and 2, 4, 6, 8, 12, and 24 hours post-dose.

Tmax of Oxycodone Oral Solution over 24 hours in a pediatric population

Outcome measures

Measure	Active n=89 Participants Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Tmax of Oxycodone Oral Solution.	2.71 Hours Standard Deviation 2.67

Adverse Events

Active

Serious events: 0 serious events

Other events: 20 other events

Deaths: 21 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=97 participants at risk Open label pharmacokinetic study of oxycodone. Oxycodone: Pain
Blood and lymphatic system disorders Anaemia	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Gastrointestinal disorders abdominal Pain Upper	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Gastrointestinal disorders nausea	13.4% 13/97 • Number of events 13 • Adverse events were collected over the course of the study (4 years)
Gastrointestinal disorders Vomiting	12.4% 12/97 • Number of events 12 • Adverse events were collected over the course of the study (4 years)
General disorders application site pruritus	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
General disorders Chills	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
General disorders Injection site erythema	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
General disorders Pyrexia	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Immune system disorders Drug Hypersenstivity	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Investigations Alanine amniotransferase increased	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Investigations Blood phosphorus decreased	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Investigations Haematocrit decreased	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Investigations Liver function test increased	2.1% 2/97 • Number of events 2 • Adverse events were collected over the course of the study (4 years)
Investigations Oxygen saturation decreased	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Investigations Red blood cell count decreased	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Musculoskeletal and connective tissue disorders Neck Pain	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Nervous system disorders Dizziness	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Nervous system disorders Headache	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Psychiatric disorders Anxiety	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Skin and subcutaneous tissue disorders Erythema	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)
Skin and subcutaneous tissue disorders Pruritus	8.2% 8/97 • Number of events 8 • Adverse events were collected over the course of the study (4 years)
Skin and subcutaneous tissue disorders Pruritus generalized	1.0% 1/97 • Number of events 1 • Adverse events were collected over the course of the study (4 years)

Additional Information

Study Director

PPSI

Phone: 8139279302

Email: mgoodhead@pharmaprojectsolutions.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place