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