drugset / Trial / NCT05144295
Lubiprostone for Functional Constipation in the Under 18 Years Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigators will enroll subjects 8 - \< 18 years of age, fulfilling Rome IV criteria for functional constipation. Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets). safety and efficacy will be assessed.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2022-08-25
- Completion
- 2022-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bisacodyl | Small molecule | 10 mg | Oral |
| Comparator | Bisacodyl | Small molecule | 15 mg | Oral |
| Comparator | Lactulose Oral Liquid Product | Unknown | 1 unknown | Oral |
| Subject | Lubiprostone | Small molecule | 8 ug | Oral |
| Subject | Lubiprostone | Small molecule | 24 ug | Oral |
| Comparator | Sodium Picosulfate | Unknown | 2.5 mg | Oral |
| Comparator | Sodium Picosulfate | Unknown | 20 mg | Oral |
Indications
No indication recorded.