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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy, Safety, and Tolerability of Prucalopride in Men With Chronic Constipation

Yiannakou, Yan MD1; Piessevaux, Hubert MD2; Bouchoucha, Michel MD3; Schiefke, Ingolf MD4; Filip, Rafal MD5; Gabalec, Libor MD6; Dina, Ion MD7; Stephenson, David BSc8; Kerstens, René MSc9; Etherson, Kevin MB, ChB1; Levine, Amy MD10

American Journal of Gastroenterology: May 2015 - Volume 110 - Issue 5 - p 741–748
doi: 10.1038/ajg.2015.115
ORIGINAL CONTRIBUTIONS: FUNCTIONAL GI DISORDERS
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OBJECTIVES: 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.

1Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Durham, UK

2Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium

3Université Paris V-René-Descartes, Paris, France

4Klinik fìr Gastroenterologie und Hepatologie, Klinikum St Georg, Leipzig, Germany

5Institute of Rural Health, Lublin, Poland

6Orlickoústecká nemocnice, Ústí nad Orlicí, Czech Republic

7University of Medicine and Pharmacy Carol Davila, Bucharest, Romania

8Shire, Basingstoke, UK

9Shire-Movetis NV, Turnhout, Belgium

10Shire, Wayne, Pennsylvania, USA

Correspondence: Yan Yiannakou, MD, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Durham DH1 5TW, UK. E-mail: yan.yiannakou@cddft.nhs.uk

SUPPLEMENTARY MATERIAL accompanies this paper at http://links.lww.com/AJG/B74

Received 15 October 2014; accepted 03 March 2015

Guarantor of the article: Yan Yiannakou, MD.

Specific author contributions: R.K. contributed to the concept and design of the study. A.L., H.P., K.E., R.K., and Y.Y. were involved in data acquisition and analysis. All authors contributed to data interpretation and critically reviewed the manuscript. All authors approved the final version of the manuscript.

Financial support: This study was funded in full by Shire-Movetis NV.

Potential competing interests: H.P. has received lecture fees and travel grants from Shire. Y.Y. has received lecture fees, a travel and educational grants from Shire. K.E. has received a travel grant from Shire. A.L. is an employee and shareholder of Shire. R.K. was an employee of Shire at time of the study. D.S. was an employee and shareholder of Shire at the time of the study. The remaining authors declare no conflict of interest.

© The American College of Gastroenterology 2015. All Rights Reserved.
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