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Lubiprostone for Functional Constipation in the Under 18 Years Patients

NCT05144295 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2022-11-15

No results posted yet for this study

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.

Conditions

  • Clinical Efficacy
  • Treatment Efficacy
  • Drug Side Effect

Interventions

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Sameh A. Lashen, MD (Ph.D.) · Faculty of Medicine, Alexandria University - Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-08-25
Completion
2022-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144295 on ClinicalTrials.gov