What side effects are associated with this type of intervention?

Prucalopride, a selective serotonin 5-HT4 receptor agonist, is used to stimulate colonic motility and treat functional constipation. Common side effects of prucalopride include headache, abdominal pain, nausea, and diarrhea. Other treatments for constipation, such as fiber supplements, can cause bloating and gas, while stimulant laxatives may lead to abdominal cramping and electrolyte imbalances. Osmotic laxatives can cause bloating, gas, and dehydration if not taken with adequate fluids. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for constipation, particularly chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C). Prucalopride, a selective serotonin 5-HT4 receptor agonist, stimulates colonic motility and is one such treatment. Other similar FDA-approved drugs include lubiprostone, a chloride channel activator, and linaclotide, a guanylate cyclase-C agonist, both of which increase intestinal fluid secretion and transit. Plecanatide, another guanylate cyclase-C agonist, is also approved for similar indications. These treatments aim to enhance bowel movements and alleviate symptoms associated with constipation.

What other types of research exist?

Promising novel alternatives to Prucalopride for constipation treatment include Lubiprostone, a chloride channel activator that enhances intestinal fluid secretion, and Guanylate cyclase agonists like Linaclotide and Plecanatide, which stimulate intestinal fluid secretion and transit. These alternatives have shown efficacy in clinical trials and may offer new options for patients in 2024.

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Serotonin-4 Receptor Agonist

Prucalopride for Constipation

Phase 3

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug up to week 52

Awards & highlights

Pivotal Trial

Summary

This trial tests prucalopride, a medicine that helps improve bowel movements, in children and teenagers aged 3 to 17 with functional constipation. The study will check if prucalopride works and if it has any side effects. Participants will be given either a low dose or a high dose for several months, with an option to continue for a longer period. Prucalopride has been shown to improve bowel function in adults with chronic constipation.

Who is the study for?

This trial is for children and teenagers aged 6 months to 17 years with functional constipation, which means they have difficulty passing stools not caused by other health issues or medications. They must weigh at least 5.5 kg (12 lbs), be toilet-trained if over 3 years old, and experience less than three bowel movements per week among other specific criteria related to stool characteristics.

What is being tested?

The study tests prucalopride's effectiveness in improving bowel movements in young patients with functional constipation. It has two parts: the first part randomly assigns participants to a low dose of prucalopride, a higher dose, or a placebo for 12 weeks; the second part continues treatment for another 36 weeks, with placebo group members switching to prucalopride.

What are the potential side effects?

Possible side effects from prucalopride may include abdominal pain, diarrhea, headache, nausea, fatigue and an increase in heart rate. The severity of these side effects can vary between individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Change From Baseline in Average Number of Weekly Number of Spontaneous Bowel Movements (SBMs) at Week 12

Parts A and B: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters

Parts A and B: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

+2 more

Secondary study objectives

Part A: Change From Baseline in Participants' Weekly Stool Consistency Based on Bristol Stool Form Scale (BSFS) Score at Week 12 Categorized by Age

Part A: Change From Baseline in Weekly Straining Score Based on a 3-point Likert Scale at Week 12

Part A: Percentage of Participants With Fecal Incontinence at Week 12

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: Low Dose PrucaloprideExperimental Treatment1 Intervention

Participants weighing \<50 kg will receive 0.04 mg/kg of prucalopride oral solution (will draw the required volume from one bottle of 0.4 mg/mL and one bottle of placebo oral solution to account for the daily dose assigned), QD or participants weighing ≥50 kg will receive one 2 mg of prucalopride oral tablet and one placebo oral tablet, QD, for 36 weeks during the 40-week Part B Period. Prucalopride (oral solution or tablet) will be dosed depending on the participant's BW at the randomization visit.

Group II: Part B: High Dose PrucaloprideExperimental Treatment1 Intervention

Participants weighing \<50 kg will receive 0.08 mg/kg of prucalopride oral solution (will draw the required volume from two bottles of 0.4 mg/mL to account for the daily dose assigned), QD or participants weighing ≥50 kg will receive two 2 mg of prucalopride oral tablets, QD, for 36 weeks during the 40-week Part B Period. Prucalopride (oral solution or tablet) will be dosed depending on the participant's BW at the randomization visit.

Group III: Part A: Low Dose PrucaloprideExperimental Treatment1 Intervention

Participants weighing \<50 kg will receive 0.04 milligrams per kilogram (mg/kg) of prucalopride oral solution (will draw the required volume from one bottle of 0.4 milligram per milliliter \[mg/mL\] and one bottle of placebo oral solution), QD or participants weighing ≥50 kg will receive one 2 milligram (mg) of prucalopride oral tablet and one placebo oral tablet, QD, during 12 weeks in Part A. Prucalopride (oral solution or tablet) will be dosed depending on the participant's BW at the randomization visit.

Group IV: Part A: High Dose PrucaloprideExperimental Treatment1 Intervention

Participants weighing \<50 kg will receive 0.08 mg/kg of prucalopride oral solution (will draw the required volume from two bottles of 0.4 mg/mL to account for the daily dose assigned), QD or participants weighing ≥50 kg will receive two 2 mg of prucalopride oral tablets, QD, during 12 weeks of treatment period in Part A. Prucalopride (oral solution or tablet) will be dosed depending on the participant's BW at the randomization visit.

Group V: Part A: PlaceboPlacebo Group1 Intervention

Participants weighing \<50 kilograms (kg) will draw equal volumes from two bottles of placebo oral solution to account for the daily dose assigned or participants weighing ≥ 50 kg will receive two placebo oral tablets, once daily (QD), during 12 weeks in Part A. Prucalopride matching placebo (oral solution or tablet) will be dosed depending on the participant's body weight (BW) at the randomization visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prucalopride

2013

Completed Phase 4

~5850

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prucalopride, a selective serotonin 5-HT4 receptor agonist, stimulates colonic motility by enhancing the peristaltic reflex and accelerating colonic transit. This is particularly beneficial for patients with functional constipation as it directly addresses the underlying issue of slow bowel movements. Other common treatments include bulk-forming agents like psyllium, which increase stool bulk and trigger bowel movements; osmotic laxatives like polyethylene glycol, which draw water into the bowel to soften stools and stimulate bowel movements; stimulant laxatives like bisacodyl, which induce bowel contractions; and stool softeners like docusate, which ease stool passage by increasing water and fat penetration. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the specific cause and severity of constipation.

Characterization of 5-hydroxytryptamine (5-HT) receptor subtypes influencing colonic motility in conscious dogs.