NCT05144295

Lubiprostone for Functional Constipation in the Under 18 Years Patients

Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups. Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid. The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years. Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16). Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).

Conditions

• Clinical Efficacy
• Treatment Efficacy
• Drug Side Effect

Interventions

Type	Name	Description
DRUG	Lubiprostone Pill	Oral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight.
DRUG	Lactulose Oral Liquid Product	Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)
DRUG	Bisacodyl 5 MG	Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years
DRUG	Sodium Picosulfate	Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-08-25
• Completion: 2022-11-01
• First posted: 2021-12-03
• Last updated: 2022-11-15

Locations

2 sites across 1 country: Egypt