Lubiprostone for Functional Constipation in the Under 18 Years Patients

NCT ID: NCT05144295

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-01

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).

Conditions

Clinical Efficacy; Treatment Efficacy; Drug Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lubiprostone Pill

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Lactulose Oral Liquid Product

Intervention Type: DRUG

Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)

Bisacodyl 5 MG

Intervention Type: DRUG

Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for \< 12 years or 3 tab/day for \> 12 years

Sodium Picosulfate

Intervention Type: DRUG

Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day

Interventions

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.

Intervention Type: DRUG

Lactulose Oral Liquid Product

Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day)

Intervention Type: DRUG

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

Intervention Type: DRUG

Sodium Picosulfate

Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day

Intervention Type: DRUG

Other Intervention Names

Amiprostone 8 mcg caps; Amiprostone 24 mcg caps; Lubicont 8 mcg caps; Lactulose OR Duphalac; Bisacodyl 5 mg tablets; Bisadyl 0.75% drops

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Sameh A. Lashen

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh A. Lashen, MD (Ph.D.)

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Alexandria University - Alexandria

Locations

Alexandria Main University Hospital

Alexandria, , Egypt

Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0305299

Identifier Type: -

Identifier Source: org_study_id