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.

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

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.

• 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

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

• 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.

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.