PEP Topic 

Prucalopride is a selective, high-affinity 5-HT4 agonist that targets impaired motility in the gastrointestinal tract. This drug has been examined for the treatment of constipation.

Effectiveness Not Established

Research Evidence Summaries

Quigley, E.M., Vandeplassche, L., Kerstens, R., & Ausma, J. (2009). Clinical trial: The efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation—A 12-week, randomized, double-blind, placebo-controlled study. Alimentary Pharmacology and Therapeutics, 29, 315–328.

doi: 10.1111/j.1365-2036.2008.03884.x

Study Purpose:

To evaluate the effectiveness and safety of prucalopride, a 5-HT4 receptor agonist, in patients with chronic constipation.

Intervention Characteristics/Basic Study Process:

Patients with self-reported chronic constipation for at least six months could enroll in the study. The 12-week study procedure comprised a two-week placebo run-in period to determine frequency of bowel movements (BMs). Patients with two or fewer spontaneous complete BMs per week were randomized to one of three treatment groups (2-mg prucalopride, 4-mg prucalopride, or placebo), with study medication taken once daily with breakfast for 10 weeks.

Sample Characteristics:

  • The study reported on a sample of 641 patients.
  • Mean patient age was 47.9 years (range 18–95).
  • The sample comprised 555 women (87%) and 86 men (13%).
  • Patients were aged older than 18 years and had a history of self-reported chronic constipation for six months or less that was not caused by drug use, surgery, or organic disorders of the large intestine.


  • Multi-site
  • United States

Study Design:

This was a randomized, double-blind, placebo-controlled, parallel-group phase III trial.

Measurement Instruments/Methods:

  • Patient diary
  • Patient global assessments
  • Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
  • Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
  • Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36)


  • Significantly more patients in the prucalopride 2-mg (23.9%) and 4-mg (23.5%) groups reported three or more spontaneous complete BMs per week compared with the placebo group (12.1%) over the 12-week study period (p ≤ 0.01).
  • Significantly more patients in the prucalopride 2-mg (42.6%) and 4-mg (46.6%) groups reported an increase from baseline of at least one spontaneous complete BM per week compared with the placebo group (27.5%) over the 12-week study period (p ≤ 0.001).
  • Patients in both prucalopride groups had an increased percentage of normal consistency BMs (p ≤ 0.05), had no straining (p ≤ 0.01), used significantly fewer laxatives per week (p ≤ 0.01), used fewer enemas per week (p ≤ 0.05), rated their treatment effectiveness better (p ≤ 0.001), and rated their constipation as less severe (p ≤ 0.001) compared with the placebo group.
  • The most common adverse events were headache, nausea, abdominal pain, diarrhea, and flatulence.


Prucalopride 2-mg and 4-mg administration improved the frequency, consistency, and quality of defecation and led to complete bowel evacuation in adults with chronic constipation.


  • Patients who had cancer or were receiving opioid therapy were excluded from the study.
  • Eighty-seven percent of the participants were women.

Nursing Implications:

Prucalopride (2 mg or 4 mg daily) appeared effective in the treatment of chronic constipation in adults. Research for applicability in patients with cancer is warranted.