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NCT05144295 | Completed | Clinical Efficacy

Lubiprostone for Functional Constipation in the Under 18 Years Patients
Sponsor:

Alexandria University

Information provided by (Responsible Party):

Sameh A. Lashen

Brief 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.

Condition or disease

Clinical Efficacy

Treatment Efficacy

Drug Side Effect

Intervention/treatment

Lubiprostone Pill

Lactulose Oral Liquid Product

Bisacodyl 5 MG

Sodium Picosulfate

Phase

Phase 3

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).}}

Study Type : Interventional
Estimated Enrollment : 274 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : August 25, 2022
Estimated Study Completion Date : November 1, 2022
Arm Intervention/treatment

Experimental: Investigational Arm

Patients will receive lubiprostone capsules (Amiprostone 8 and 24 mcg, or Lubicont 8 mcg) Patients weighing <50 kg will be given lubiprostone at doses of 8 mcg/8 hours. Patients weighing ≥ 50 kg will be given lubiprostone at doses of 24 mcg BID. Patients 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.

Drug: Lubiprostone Pill

Drug: Lactulose Oral Liquid Product

Active Comparator: Control Arm

Subjects will receive the conventional therapy (one or a combination of the following): Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day), Bisacodyl tablets " Bisacodyl 5 mg/tablet" in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years, or Sodium Picosulfate 0.75% drops (Picolax drops) in a daily dose of 2.5-20 mg/day.

Drug: Bisacodyl 5 MG

Drug: Sodium Picosulfate
Ages Eligible for Study: 8 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients 8 - < 18 years of age who have a confirmed diagnosis of Pediatric functional constipation according to the Rome IV criteria, who give written informed consent personally or from their legal guardians.
  • Discontinuation of any medication affecting gastrointestinal (GI) motility at least 2 weeks before starting the treatment allocation.
  • Patient's daily diary that indicates an average of < 3 weekly spontaneous bowel movements (SBMs), with ≥ 25% of SBMs involving at least some straining and/or a 5-point modified Bristol Stool Form Scale type 1 or 2.
  • Patients who completed the study protocol.
Exclusion Criteria
  • If the patient's constipation is attributed to any of the following: physical, mental, or cognitive illness, inflammatory bowel disease, medication, anatomical, neurological, endocrine, or metabolic factors.
  • If the patient is a candidate for or underwent abdominal surgery, or has any condition other than constipation that could affect gastrointestinal motility or defecation.
  • Patients suffering from Hirschsprung's disease.
  • Patients experiencing any alarming signs e.g. unexplained significant weight loss.
  • Untreated fecal impaction at the time of enrollment.
Lubiprostone for Functional Constipation in the Under 18 Years Patients

Location Details

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Lubiprostone for Functional Constipation in the Under 18 Years Patients

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Locations

Not yet recruiting

Egypt,

Alexandria Main University Hospital

Alexandria, Egypt, 21521

Not yet recruiting

Egypt,

Faculty of Medicine

Alexandria, Egypt, 21521