A Phase 3 interventional study of Lubiprostone in Constipation - Functional, sponsored by Sucampo Pharma Americas, LLC. Completed at 13 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Sucampo Pharma Americas, LLC · Phase 3, Interventional, and Treatment
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 87 is close to the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Sucampo Pharma Americas, LLC is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Lubiprostone
12 or 24 mcg soft capsules for oral administration.
Also known as: Amitiza
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
| Milestone | Lubiprostone |
|---|---|
| Started | 87 |
| Treated (safety [saf] population) | 87 |
| Completed | 53 |
| Not completed | 34 |
| Withdrew: Adverse event | 12 |
| Withdrew: Lost to follow-up | 16 |
| Withdrew: Non-compliance with study drug | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 4 |
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.
| Participants | Lubiprostone |
|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | 47 |
Collected over From the first dose of study drug up to 25 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lubiprostone | 0/87 (0%) | 2/87 (2.3%) | 24/87 (27.6%) |
| Event | Lubiprostone |
|---|---|
| Colitis ulcerativeGastrointestinal disorders | 1/87 |
| ConstipationGastrointestinal disorders | 1/87 |
| Event | Lubiprostone |
|---|---|
| DiarrhoeaGastrointestinal disorders | 8/87 |
| VomitingGastrointestinal disorders | 6/87 |
| NauseaGastrointestinal disorders | 5/87 |
| Blood iron decreasedInvestigations | 5/87 |
Safety (SAF) population, defined as all enrolled participants who took at least one dose of study medication.
| Age, Continuous(years) | Lubiprostone |
|---|---|
| Mean | 10.3 ± 3.03 |
| Sex: Female, Male(Participants) | Lubiprostone |
|---|---|
| Female | 49 |
| Male | 38 |
| Ethnicity (NIH/OMB)(Participants) | Lubiprostone |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 77 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Lubiprostone |
|---|---|
| Black or African American | 16 |
| White | 68 |
| Other | 3 |
| Region of Enrollment(Participants) | Lubiprostone |
|---|---|
| United States | 87 |
Plan to share: No
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Sucampo Pharma Americas, LLC