Lubiprostone for Functional Constipation in the Under 18 Years Patients
Condition: Clinical Efficacy; Treatment Efficacy; Drug Side Effect
MeSH terms: Constipation; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Lubiprostone Pill; Lactulose Oral Liquid Product; Bisacodyl 5 MG; Sodium Picosulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day); Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years; Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day
Other intervention name(s): Amiprostone 8 mcg caps; Amiprostone 24 mcg caps; Lubicont 8 mcg caps; Lactulose OR Duphalac; Bisacodyl 5 mg tablets; Bisadyl 0.75% drops
Intervention MeSH terms: Lactulose; Bisacodyl; Picosulfate sodium; Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing <50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively.
Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid.
The control group will receive the conventional therapy (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).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lubiprostone; Functional constipation; Adolescent; Children; Spontaneous Bowel Motions; Drug safety