Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies

Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.


Background: Prucalopride is approved in Europe for symptomatic treatment of chronic constipation in women with inadequate relief from laxatives.

Aim: To evaluate efficacy of prucalopride during long-term treatment of patients with chronic constipation.

Methods: Patients from three pivotal double-blind, placebo-controlled, 12-week studies with prucalopride could continue treatment in open-label studies up to 24 months. Efficacy was evaluated every 3 months using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) satisfaction scale. Laxative use and reasons for study discontinuation were recorded.

Results: Eighty-six percent of patients who completed the pivotal studies continued prucalopride treatment in the open-label studies (n = 1455, 90% female). Improvement in average PAC-QOL satisfaction score observed after 12-week, double-blind prucalopride was maintained during open-label treatment for up to 18 months; in each 3 month period, 40-50% of patients did not use any laxatives. Most frequent adverse events (AEs) resulting in discontinuation were gastrointestinal events (3.3%) and headache (1.0%). Only 10% of patients who had normalized bowel function on prucalopride at the end of pivotal trials discontinued due to insufficient response during open-label treatment.

Conclusion: Satisfaction with bowel function is maintained for up to 18 months of treatment with prucalopride. Gastrointestinal events and headache cause discontinuation of prucalopride treatment in ∼5% of patients ( identifiers: NCT01070615 and NCT00987844).

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Benzofurans / therapeutic use*
  • Chronic Disease
  • Constipation / drug therapy*
  • Defecation / drug effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Laxatives / therapeutic use*
  • Male
  • Middle Aged
  • Pilot Projects
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Serotonin 5-HT4 Receptor Agonists / therapeutic use*
  • Statistics as Topic
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Benzofurans
  • Laxatives
  • Serotonin 5-HT4 Receptor Agonists
  • prucalopride

Associated data