Lubiprostone for Functional Constipation in the Under 18 Years Patients

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Drug Side Effect; Treatment Efficacy; Clinical Efficacy

Treatments: Drug: Bisacodyl 5 MG; Drug: Sodium Picosulfate; Drug: Lactulose Oral Liquid Product; Drug: Lubiprostone Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT05144295

0305299

Details and patient eligibility

About

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.

Full 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).

Enrollment: 274 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

1. 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.
2. 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.
3. Patients suffering from Hirschsprung's disease.
4. Patients experiencing any alarming signs e.g. unexplained significant weight loss.
5. Untreated fecal impaction at the time of enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups

Investigational Arm

Experimental group

Description:

* 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.

Treatment:

Drug: Lubiprostone Pill

Control Arm

Active Comparator group

Description:

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.

Treatment:

Drug: Lactulose Oral Liquid Product

Drug: Bisacodyl 5 MG

Drug: Sodium Picosulfate