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Lubiprostone for Functional Constipation in the Under 18 Years Patients

Primary Purpose

Clinical Efficacy, Treatment Efficacy, Drug Side Effect

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Lubiprostone Pill

Lactulose Oral Liquid Product

Bisacodyl 5 MG

Sodium Picosulfate

About this trial

This is an interventional treatment trial for Clinical Efficacy focused on measuring Lubiprostone, Functional constipation, Adolescent, Children, Spontaneous Bowel Motions, Drug safety

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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:

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.

Sites / Locations

Alexandria Main University Hospital
Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Arm

Control Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Early spontaneous bowel motions

Number of participants who experienced first SBM within 48 hours after dose initiation.

First dose response time

The time between first dose of treatment and the first SBM.

Number of Spontaneous Bowel Motions/Week.

Responders rate

Responders rate at week 8, 12, 16.

Full Information

NCT ID

NCT05144295

First Posted

November 22, 2021

Last Updated

November 12, 2022

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05144295

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

August 25, 2022 (Actual)

Study Completion Date

November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinical Efficacy, Treatment Efficacy, Drug Side Effect

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

274 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lubiprostone Pill

Other Intervention Name(s)

Amiprostone 8 mcg caps, Amiprostone 24 mcg caps, Lubicont 8 mcg caps

Intervention Description

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

Intervention Name(s)

Lactulose Oral Liquid Product

Other Intervention Name(s)

Lactulose OR Duphalac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bisacodyl 5 MG

Other Intervention Name(s)

Bisacodyl 5 mg tablets

Intervention Description

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

Intervention Name(s)

Sodium Picosulfate

Other Intervention Name(s)

Bisadyl 0.75% drops

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary outcome

Description

Time Frame

At study week 16.

Secondary Outcome Measure Information:

Title

Early spontaneous bowel motions

Description

Number of participants who experienced first SBM within 48 hours after dose initiation.

Time Frame

First 48 hours after first drug dose.

Title

First dose response time

Description

The time between first dose of treatment and the first SBM.

Time Frame

1st week of treatment

Title

Number of Spontaneous Bowel Motions/Week.

Description

Number of Spontaneous Bowel Motions/Week.

Time Frame

At study week Week 8, 12.

Title

Responders rate

Description

Responders rate at week 8, 12, 16.

Time Frame

At study week Week 8, 12, 16.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Faculty of Medicine, Alexandria University - Alexandria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alexandria Main University Hospital

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

Facility Name

Faculty of Medicine

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

patient personal and identification data will not be available for sharing

Learn more about this trial

Lubiprostone for Functional Constipation in the Under 18 Years Patients

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