Lubiprostone for Functional Constipation in the Under 18 Years Patients

Treatment Efficacy Clinical Trial

Official title:

Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05144295
• Other study ID #: 0305299
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: November 1, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Efficacy
• Constipation
• Drug Side Effect
• Drug-Related Side Effects and Adverse Reactions
• Treatment Efficacy

Intervention

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.
• Lactulose Oral Liquid Product
Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)
• 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
• Sodium Picosulfate
Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day

Locations

Country	Name	City	State
Egypt	Alexandria Main University Hospital	Alexandria
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome	Spontaneous bowel motions (SBM) = 1 SBM/week increase in the frequency compared with baseline, and = 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up.	At study week 16.
Secondary	Early spontaneous bowel motions	Number of participants who experienced first SBM within 48 hours after dose initiation.	First 48 hours after first drug dose.
Secondary	First dose response time	The time between first dose of treatment and the first SBM.	1st week of treatment
Secondary	Number of Spontaneous Bowel Motions/Week.	Number of Spontaneous Bowel Motions/Week.	At study week Week 8, 12.
Secondary	Responders rate	Responders rate at week 8, 12, 16.	At study week Week 8, 12, 16.