Trial Outcomes & Findings for Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients (NCT NCT02321319)

Last Updated: 2020-05-21

Results Overview

Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

28 days

Results posted on

2020-05-21

Participant milestones
Measure	Hydromorphone HCl ER Tablets Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Hydromorphone HCl ER Tablets Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
Overall Study Product discontinued	5

Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients

Baseline characteristics by cohort
Measure	Hydromorphone HCl ER Tablets n=5 Participants Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
Age, Categorical <=18 years	5 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
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White · Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized White · Non-hispanic	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

Timeframe: 28 days

Population: All participants

Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs

Outcome measures
Measure	Hydromorphone HCl ER Tablets n=5 Participants Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
Number of Participants With Adverse Events (AEs)	1 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Hydromorphone HCl ER Tablets n=5 participants at risk Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)
General disorders Itching	20.0% 1/5 • Number of events 1 • 28 days, including a 3-week extension
General disorders Fever of unknown origin	20.0% 1/5 • Number of events 1 • 28 days, including a 3-week extension
Infections and infestations Leukocytosis	20.0% 1/5 • Number of events 1 • 28 days, including a 3-week extension

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