Constipation - Functional
Conditions
Brief summary
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.
Detailed description
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
Interventions
DRUGLubiprostone
12 or 24 mcg soft capsules for oral administration.
Sponsors
Sucampo AG
Sucampo Pharma Americas, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation * At least 6 years of age but less than 18 years of age at the time of randomisation * Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants
Exclusion criteria
* Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation * Untreated faecal impaction at the time of screening * Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | within 25 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Lubiprostone |
|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 3.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 68 Participants |
| Region of Enrollment United States | 87 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 87 |
| other Total, other adverse events | 24 / 87 |
| serious Total, serious adverse events | 2 / 87 |
Outcome results
Primary
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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.
Time frame: within 25 weeks
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lubiprostone | Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | 47 Participants |