Trial Outcomes & Findings for Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects (NCT NCT01322360)

Results Overview

The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade. Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2018-02-05

Participant Flow

Recruitment 06 May 2011 to 10 April 2012. A total of 75 subjects were screened and 50 subjects were enrolled (i.e., received at least 1 dose of study drug)

Only eligible pediatric subjects who signed the informed consent and completed all screening procedures within 14 days before the surgery were enrolled in the study.

Participant milestones

Participant milestones
Measure	Morphine Sulfate Morphine sulfate oral solution and Morphine sulfate tablets
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine Sulfate n=50 Participants Morphine sulfate oral solution and Morphine sulfate tablets
Age, Categorical <=18 years	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9.3 years STANDARD_DEVIATION 5.03 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: 75 subjects were screened and 50 subjects took at least one dose of oral morphine sulfate.

The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade. Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator.

Outcome measures

Outcome measures
Measure	Morphine Sulfate n=50 Participants Subjects received morphine sulfate either as oral solution or tablet.
Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation	1 participants

SECONDARY outcome

Timeframe: Up to 21 days

Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade

Outcome measures

Outcome measures
Measure	Morphine Sulfate n=50 Participants Subjects received morphine sulfate either as oral solution or tablet.
Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade	19 participants

Adverse Events

Morphine Sulfate

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Morphine Sulfate n=50 participants at risk Morphine sulfate oral solution and Morphine sulfate tablets
Gastrointestinal disorders Ileus	2.0% 1/50 • Number of events 1 • Adverse event reports began with first dose of study drug through end of study.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/50 • Number of events 1 • Adverse event reports began with first dose of study drug through end of study.

Other adverse events

Other adverse events
Measure	Morphine Sulfate n=50 participants at risk Morphine sulfate oral solution and Morphine sulfate tablets
Gastrointestinal disorders Nausea	36.0% 18/50 • Number of events 18 • Adverse event reports began with first dose of study drug through end of study.
Gastrointestinal disorders Constipation	34.0% 17/50 • Number of events 17 • Adverse event reports began with first dose of study drug through end of study.
Investigations Oxygen Saturation Decreased	22.0% 11/50 • Number of events 11 • Adverse event reports began with first dose of study drug through end of study.
General disorders Pyrexia	16.0% 8/50 • Number of events 8 • Adverse event reports began with first dose of study drug through end of study.
Skin and subcutaneous tissue disorders Pruritus	14.0% 7/50 • Number of events 7 • Adverse event reports began with first dose of study drug through end of study.
Respiratory, thoracic and mediastinal disorders Tachypnoea	18.0% 9/50 • Number of events 9 • Adverse event reports began with first dose of study drug through end of study.
Psychiatric disorders Anxiety	10.0% 5/50 • Number of events 5 • Adverse event reports began with first dose of study drug through end of study.

Additional Information

Anton (Tony) Amann, PhD, Executive Director, Drug Regulatory and Medical Affairs

Roxane Laboratories, Inc

Phone: 614-272-4785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60