title: A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation.
abstract: OBJECTIVE
  Prucalopride is effective at alleviating symptoms of chronic constipation in women. The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation.
  
  
  METHODS
  This was a multicenter, stratified, randomized, parallel-group, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov identifier: NCT01147926). The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week across the treatment period. Efficacy end points were assessed using daily electronic diaries, global assessment of the severity of constipation and efficacy of treatment, and Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires.
  
  
  RESULTS
  In total, 374 patients were enrolled in the study. Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group (37.9%) than in the placebo group (17.7%, P<0.0001). The proportion of patients rating their constipation treatment as "quite a bit" to "extremely" effective at the final on-treatment visit was 46.7 and 30.4% in the prucalopride and placebo groups, respectively. The difference between treatment groups was statistically significant (P<0.0001). The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8% in the prucalopride and placebo groups, respectively (P=0.0035). Prucalopride had a good safety profile and was well tolerated.
  
  
  CONCLUSIONS
  Prucalopride is effective, has a good safety profile, and is well tolerated for the treatment of men with chronic constipation.
authors: Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Durham, UK.
authors: Yan
authors: Y
authors: Yiannakou
authors: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
authors: Hubert
authors: H
authors: Piessevaux
authors: Université Paris V-René-Descartes, Paris, France.
authors: Michel
authors: M
authors: Bouchoucha
authors: Klinik fìr Gastroenterologie und Hepatologie, Klinikum St Georg, Leipzig, Germany.
authors: Ingolf
authors: I
authors: Schiefke
authors: Institute of Rural Health, Lublin, Poland.
authors: Rafal
authors: R
authors: Filip
authors: Orlickoústecká nemocnice, Ústí nad Orlicí, Czech Republic.
authors: Libor
authors: L
authors: Gabalec
authors: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
authors: Ion
authors: I
authors: Dina
authors: Shire, Basingstoke, UK.
authors: David
authors: D
authors: Stephenson
authors: Shire-Movetis NV, Turnhout, Belgium.
authors: René
authors: R
authors: Kerstens
authors: Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Durham, UK.
authors: Kevin
authors: K
authors: Etherson
authors: Shire, Wayne, Pennsylvania, USA.
authors: Amy
authors: A
authors: Levine
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003672:Defecation; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011788:Quality of Life; D058828:Serotonin 5-HT4 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D001572:Benzofurans; D058828:Serotonin 5-HT4 Receptor Agonists; C406662:prucalopride