Lubiprostone for Functional Constipation in the Under 18 Years Patients

Treatment Efficacy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Clinical Efficacy
• Constipation
• Drug Side Effect
• Drug-Related Side Effects and Adverse Reactions
• Treatment Efficacy

• NCT number: NCT05144295
• Study type: Interventional
• Source: Alexandria University
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Completion date: November 1, 2022