Evaluating the Efficacy & Safety of Prucalopride in Pediatric Subjects with Functional Constipation

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Evaluating the Efficacy & Safety of Prucalopride in Pediatric Subjects with Functional Constipation

Phase 3, Multicenter, Randomized Study with Two Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years with Functional Constipation, Consisting of 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48.

Primary Sponsor: Takeda Development Center Americas, Inc.

Start Date: November 18, 2022

IRB Number: 1772657

Condition/Disease: Digestive, Pediatrics

Lead Researcher: Wael Sayej

Location:

  • Baystate Children's Hospital
  • Baystate Medical Center
  • Baystate Children's Specialty Center

Purpose:
The main aim of the first part of the study is to learn if a medicine called prucalopride can improve bowel movements in children and teenagers with functional constipation. Another aim is to check for side effects from two different doses of prucalopride. The main aim of the second part of the study is to continue to check for side effects from two different doses of prucalopride.

Eligibility:

Inclusion

Participants must have <= 2 defecations per week and >= 1 month of at least 1 of the following:

  • History of excessive stool retention
  • History of painful or hard BMs
  • History of large-diameter stools (in the diaper)
  • Presence of a large fecal mass in the rectum

To be evaluated prior to randomization:

  • Participant has an average of < 3 SBMs (defecations) per week during the screening period and prior to the disimpaction.

Exclusion

  • Current or relevant history of physical or psychiatric illness (e.g. severe autism, depression, etc.), any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
  • Participant with secondary causes of constipation:
    • Endocrine disorders (e.g., hypopituitarism, hypothyroidism, hypercalcemia, pheochromocytoma, glucagon-producing tumors) unless these are controlled by appropriate medical therapy. Participant with uncontrolled diabetes mellitus is to be excluded.
    • Metabolic disorders (e.g., porphyria, uremia, hypokalemia, hypothyroidism, amyloid neuropathy), unless controlled by appropriate medical therapy.
    • Neurological disorders (e.g., cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypganglionosis, hyperganglionosis, autonomic neuropathy, spinal cord injury, Chagas disease.
    • Organic disorders (known or suspected) of the large bowl (e.g., obstruction from any cause including biliary obstruction, malignancy, intestinal perforation, obstructive ileus, pseudo-obstruction, history of or current anorectal malformations, severe inflammation of the intestinal tract, such as Crohn's diseases, ulcerative colitis or toxic megacolon/megarectum, Hirschsprung's disease).
    • Celiac disease, cow milk allergy
    • Surgery: history of gastrointestinal surgery related or possibly related to the presence of constipation
    • Lactose intolerance

Time Commitment: 48 weeks

Status: Active

Current Trial Type: Outpatient

Phase: 3

Contact Name: Wael Sayej

Phone: 413-794-5437

Email

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