Clinical trial NCT05144295: Lubiprostone for Functional Constipation in the Under 18 Years Patients
Official title: Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clinical Efficacy
Treatment Efficacy
Drug Side Effect
Keywords: Lubiprostone
Functional constipation
Adolescent
Children
Spontaneous Bowel Motions
Drug safety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 274
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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).

Eligibility 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:

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.

Primary outcomes:
measure: Primary outcome
timeFrame: At study week 16.
Secondary outcomes:
measure: Early spontaneous bowel motions
timeFrame: First 48 hours after first drug dose.
measure: First dose response time
timeFrame: 1st week of treatment
measure: Number of Spontaneous Bowel Motions/Week.
timeFrame: At study week Week 8, 12.
measure: Responders rate
timeFrame: At study week Week 8, 12, 16.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Faculty of Medicine, Alexandria University - Alexandria
name: Sameh A. Lashen, MD (Ph.D.)
role: PRINCIPAL_INVESTIGATOR
References: