CLINICAL RESPONSE TO 5HT4 RECEPTORS AGONIST (PRUCALOPRIDE): GASTROCOLIC REFLEX

CLINICAL RESPONSE TO 5HT4 RECEPTORS AGONIST (PRUCALOPRIDE): GASTROCOLIC REFLEX - GASTROCOLIC REFLEX

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000821-30-ES

Enrollment

Registered

2013-06-10

Start date

2013-07-12

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic constipation

Interventions

Trade Name: Resolor Pharmaceutical Form: Tablet INN or Proposed INN: PRUCALOPRIDE SUCCINATE Other descriptive name: PRUCALOPRIDE SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Existence of any relevant organic and/or systemic disease Use of medication(s) known to interfere with gastrointestinal motility Cases in which constipation is secondary to drugs or systemic disease(s). Inability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether 5HT4 agonist (prucalopride at a dose of 2 mg/day) increases the gastrocolic reflex in patients with chronic constipation.;Secondary Objective: - To assess whether there is a relationship between the magnitude of increased CCK levels and that of the gastrocolic reflex under physiological conditions in patients with chronic constipation. - To assess whether there is a temporal relationship between CCK levels and the duration of the gastrocolic reflex under physiological conditions in patients with chronic constipation. - To assess whether 5HT4 agonist (prucalopride 2 mg/day) induces a greater increase in postprandial serum levels of cholecystokinin in patients with chronic constipation. ;Primary end point(s): Gastrocolic reflex: defined as the decrease in rectal volume produced after eating. This is quantified as follows: Magnitude: defined as the percentage of volume decrease in the first half-hour after eating with respect to the volume 30 minutes prior to food intake. Duration: defined as the time necessary to recover 50% of the decrease in rectal volume after food intake, with a maximum of 2 hours. Gastrocolic reflex stimulation: defined as the increase in serum CCK levels after food intake, evaluating the maximum concentration achieved and the time to maximum concentration ;Timepoint(s) of evaluation of this end point: baseline appointment and at the end of the first week	—

Measure

Time frame

Main Objective: To assess whether 5HT4 agonist (prucalopride at a dose of 2 mg/day) increases the gastrocolic reflex in patients with chronic constipation.;Secondary Objective: - To assess whether there is a relationship between the magnitude of increased CCK levels and that of the gastrocolic reflex under physiological conditions in patients with chronic constipation. - To assess whether there is a temporal relationship between CCK levels and the duration of the gastrocolic reflex under physiological conditions in patients with chronic constipation. - To assess whether 5HT4 agonist (prucalopride 2 mg/day) induces a greater increase in postprandial serum levels of cholecystokinin in patients with chronic constipation. ;Primary end point(s): Gastrocolic reflex: defined as the decrease in rectal volume produced after eating. This is quantified as follows: Magnitude: defined as the percentage of volume decrease in the first half-hour after eating with respect to the volume 30 minutes prior to food intake. Duration: defined as the time necessary to recover 50% of the decrease in rectal volume after food intake, with a maximum of 2 hours. Gastrocolic reflex stimulation: defined as the increase in serum CCK levels after food intake, evaluating the maximum concentration achieved and the time to maximum concentration ;Timepoint(s) of evaluation of this end point: baseline appointment and at the end of the first week

—

Secondary

Measure	Time frame
Secondary end point(s): not aplicable;Timepoint(s) of evaluation of this end point: not aplicable	—

Countries

Spain

Contacts

Public Contactana belen rivas paterna

fundacion investigación biomedica hospital clinico san carlos

fibucicec.hcsc@salud.madrid.org00349133030003793

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026