A Study of Prucalopride For Functional Constipation in Children and Teenagers

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Constipation

In brief

Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers. This study has 2 parts: The main aim of the 1st 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 2 different doses of prucalopride. The main aim of the 2nd part of the study is to continue to check for side effects from 2 different doses of prucalopride. In the 1st part, at the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 3 treatments by chance. * A low dose of prucalopride once a day. * A higher dose of prucalopride once a day. * A placebo once a day. In this study, a placebo will look like prucalopride but will not have any medicine in it. Participants will be treated with prucalopride or a placebo for 12 weeks. Participants who took prucalopride will continue to the 2nd part of the study. They will have the same treatment as they did in the 1st part of the study. They will continue with their treatment for another 36 weeks. Participants who took placebo in the 1st part of the study will receive prucalopride in the 2nd part of the study. They will be picked for a low dose or a high dose of prucalopride by chance. Participants will visit the clinic a few times during treatment. The clinic staff will also telephone the participants, or their parents or caregivers throughout treatment for a check-up 4 weeks after last treatment, the clinic staff will telephone the participants, or their parents or caregivers for a final check-up.

Key facts

Study ID

NCT04759833

Run by

Takeda

People needed

175

Starts

2021-07-13

Expected to finish

2023-11-13

Last updated by the study team

2024-06-06

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants and/or their parent(s)/caregiver(s)/legally authorized representative(s) have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to voluntarily provide written, signed, and dated (personally or via parent[s]/caregiver[s]/legally authorized representative[s]) informed consent/assent as applicable to participate in the study.
• Note: Participants and/or parent(s)/caregiver(s)/legally authorized representative(s) (where appropriate depending on age and local regulation) can also provide consent/assent to the sparse Pharmacokinetic (PK) sampling in this study.
• Toilet-trained participants 3 years to 17 years of age, inclusive, or non-toilet-trained participants 6 months to 17 years of age, inclusive.
• Participant weighs greater than or equal to (>=) 5.5 kilograms (kg) (12 pounds [lbs]).
• Male, or non-pregnant, non-lactating female participants who are sexually active and agree to comply with the applicable contraceptive requirements of the protocol or females of non-childbearing potential.
• Note: All female participants >= 12 years and/or female participants lesser than (<) 12 years who have started menarche must have a negative serum pregnancy test at screening.
• Participant meets modified Rome IV criteria:
• For child/adolescent (aged > 4 years) functional constipation (H3a):
• Participants must have lesser than or equal to (<=) 2 defecations per week and 1 or more of the following occurring at least once per week for a minimum of 1 month:
• >= 1 episode of fecal incontinence per week (only for participants after the acquisition of toileting skills).
• History of retentive posturing or excessive volitional stool retention.
• History of painful or hard bowel movements (BMs).
• Presence of large fecal mass in rectum.
• History of large diameter stools which can obstruct the toilet. In addition, the participant does not satisfy sufficient criteria for a diagnosis of irritable bowel syndrome (IBS) and, after appropriate evaluation, the participants symptoms cannot be fully explained by another medical condition.
• For infants/toddler (aged 6 months to <= 4 years) functional constipation (G7):
• 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
• In toilet-trained children, the following additional criteria may be used:
• At least 1 episode/week of incontinence after the acquisition of toileting skills
• History of large-diameter stools which may obstruct the toilet - Participant and/or parent(s)/caregiver(s)/legally authorized representative(s) is willing to discontinue any laxatives during the screening period up to disimpaction and agrees to adhere to the protocol-specified disimpaction and rescue medication rules, if applicable.
• To be evaluated prior to randomization:

You may not qualify if…

• Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product (IP), or clinical or laboratory assessments.
• Any clinically significant abnormal findings on the electrocardiogram (ECG) that indicates a dysrhythmia or conduction abnormalities (such as abnormal heart rate, PR, QRS, or QT).
• Major cardiovascular disease such as: cardiomyopathy, cardiac insufficiency, uncorrected congenital heart disease, symptomatic valve disorders, or septal defects.
• 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.
• Non-retentive fecal incontinence.
• Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon/megarectum.
• Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied (e.g. opioids), or could affect the action, absorption, or disposition of the IP, or clinical or laboratory assessment. (Current use is defined as use within the past 5 days).
• Participants with renal impairment:
• Participants <= 2 years of age with serum creatinine greater than normal (screening sample results using central laboratory pediatric reference ranges).
• Participants > 2 years of age with severe renal impairment or end stage renal disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m\^2).
• Known or suspected intolerance or hypersensitivity to the IP(s), closely-related compounds, or any of the stated ingredients.
• Known history of alcohol or other substance abuse within the last year.
• Within 30 days prior to the first dose of the IP in the current study:
• Have used any IP.
• Have been enrolled in a clinical study (including vaccine studies) that may or may not include the administration of an IP that, in the investigator's opinion, may impact this study.
• Participant used prucalopride within 10 days prior to the first dose of the IP or has been unsuccessfully treated with prucalopride before.
• Participant meets Rome IV criteria for other Child/Adolescent Functional Gastrointestinal Disorders (FGID) (H1 - H2 and H3b).
• 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, hypoganglionosis, hyperganglionosis, autonomic neuropathy, spinal cord injury, Chagas disease
• Organic disorders (known or suspected) of the large bowel (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 disease, 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Novak Clinical Research — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Advanced Research Center, Inc. — Anaheim, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California, Davis Department of Pediatrics — Sacramento, California, United States
• University of California — San Francisco, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Pediatric & Adult Research Center — Kissimmee, Florida, United States
• Auzmer Research — Lakeland, Florida, United States
• University of Miami - Miller School of Medicine — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Florida Research Center, Inc. — Miami, Florida, United States
• Orlando Health - APH Center for Digestive Health and Nutrition — Orlando, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• GI Pediatric Subspecialty Clinic — Peoria, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• Willis-Knighton Center for Pediatric Gastroenterology & Advanced Endoscopy — Shreveport, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Baystate Health — Springfield, Massachusetts, United States
• Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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