Trial Outcomes & Findings for Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation (NCT NCT02766777)

NCT ID: NCT02766777

Last Updated: 2020-05-15

Results Overview

Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 87 participants
• Primary outcome timeframe: within 25 weeks
• Results posted on: 2020-05-15

Participant Flow

Participant milestones

Measure	Lubiprostone Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Overall Study STARTED	87
Overall Study Treated (Safety [SAF] Population)	87
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	Lubiprostone Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Overall Study Adverse Event	12
Overall Study Lost to Follow-up	16
Overall Study Non-Compliance With Study Drug	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Baseline characteristics by cohort

Measure	Lubiprostone n=87 Participants Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Age, Continuous	10.3 years STANDARD_DEVIATION 3.03 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=5 Participants
Race/Ethnicity, Customized White	68 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Region of Enrollment United States	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 25 weeks

Population: Safety population.

Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.

Outcome measures

Measure	Lubiprostone n=87 Participants Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	47 Participants

Adverse Events

Lubiprostone

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lubiprostone n=87 participants at risk Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Gastrointestinal disorders Colitis ulcerative	1.1% 1/87 • From the first dose of study drug up to 25 weeks
Gastrointestinal disorders Constipation	1.1% 1/87 • From the first dose of study drug up to 25 weeks

Other adverse events

Measure	Lubiprostone n=87 participants at risk Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Gastrointestinal disorders Diarrhoea	9.2% 8/87 • From the first dose of study drug up to 25 weeks
Gastrointestinal disorders Vomiting	6.9% 6/87 • From the first dose of study drug up to 25 weeks
Gastrointestinal disorders Nausea	5.7% 5/87 • From the first dose of study drug up to 25 weeks
Investigations Blood iron decreased	5.7% 5/87 • From the first dose of study drug up to 25 weeks

Additional Information

Medical Information Call Center

Mallinckrodt Pharmaceuticals

Phone: 800-556-3314

Email: clinicaltrials@mnk.com

Results disclosure agreements

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