Lubiprostone for Functional Constipation in the Under 18 Years Patients

NCT05144295 | Completed Phase 3

• 1 other identifier: 0305299
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 2

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.

Conditions

Clinical Efficacy; Treatment Efficacy; Drug Side Effect

Keywords

Lubiprostone; Functional constipation; Adolescent; Children; Spontaneous Bowel Motions; Drug safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Early spontaneous bowel motions

  First 48 hours after first drug dose.

• First dose response time

  1st week of treatment

• Number of Spontaneous Bowel Motions/Week.

  At study week Week 8, 12.

• Responders rate

  At study week Week 8, 12, 16.

Study Arms (2)

Investigational Arm

EXPERIMENTAL

* 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

Control Arm

ACTIVE COMPARATOR

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

Interventions

Lubiprostone Pill 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.

Also known as: Amiprostone 8 mcg caps, Amiprostone 24 mcg caps, Lubicont 8 mcg caps

Investigational Arm

Lactulose Oral Liquid Product DRUG

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

Also known as: Lactulose OR Duphalac

Control Arm

Bisacodyl 5 MG DRUG

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

Also known as: Bisacodyl 5 mg tablets

Control Arm

Sodium Picosulfate DRUG

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

Also known as: Bisadyl 0.75% drops

Control Arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Alexandria Main University Hospital

Alexandria, 21521, Egypt

Location

Faculty of Medicine

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Lubiprostone; Capsules; Lactulose; Bisacodyl; picosulfate sodium

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sameh A. Lashen, MD (Ph.D.)

  Faculty of Medicine, Alexandria University - Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: 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).

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: January 1, 2022
• Primary Completion: August 25, 2022
• Study Completion: November 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)