Lubiprostone for Functional Constipation in the Under 18 Years Patients

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05144295
Collaborator
(none)
274
2
2
11
137
12.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lubiprostone Pill
  • Drug: Lactulose Oral Liquid Product
  • Drug: Bisacodyl 5 MG
  • Drug: Sodium Picosulfate
Phase 3

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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)
Primary Purpose:
Treatment
Official Title:
Lubiprostone for the Treatment of Functional Constipation in the Under 18 Years Patients: A Randomized, Controlled Trial.
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Amiprostone 8 mcg caps
  • Amiprostone 24 mcg caps
  • Lubicont 8 mcg caps
  • Active Comparator: 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.

    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)
    Other Names:
  • Lactulose OR Duphalac
  • 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
    Other Names:
  • Bisacodyl 5 mg tablets
  • Drug: Sodium Picosulfate
    Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day
    Other Names:
  • Bisadyl 0.75% drops
  • Outcome Measures

    Primary Outcome Measures

    1. Primary outcome [At study week 16.]

      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

    1. Early spontaneous bowel motions [First 48 hours after first drug dose.]

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

    2. First dose response time [1st week of treatment]

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

    3. Number of Spontaneous Bowel Motions/Week. [At study week Week 8, 12.]

      Number of Spontaneous Bowel Motions/Week.

    4. Responders rate [At study week Week 8, 12, 16.]

      Responders rate at week 8, 12, 16.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria Main University Hospital Alexandria Egypt 21521
    2 Faculty of Medicine Alexandria Egypt 21521

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    • Principal Investigator: Sameh A. Lashen, MD (Ph.D.), Faculty of Medicine, Alexandria University - Alexandria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sameh A. Lashen, Associate Professor of Internal Medicine, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05144295
    Other Study ID Numbers:
    • 0305299
    First Posted:
    Dec 3, 2021
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Sameh A. Lashen, Associate Professor of Internal Medicine, Alexandria University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022