A randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of long-term treatment with prucalopride

Neurogastroenterology and Motility

Volumn 27, Issue 6, 2015, Pages 805-815

  Piessevaux, H ^a   Corazziari, E ^b   Rey, E ^c   Simren, M ^d   Wiechowska Kozlowska, A ^e   Kerstens, R ^f   Cools, M ^f   Barrett, K ^g   Levine, A ^h  

^a CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^d UNIVERSITY OF GOTHENBURG   (Sweden)

^e Niepubliczny Zak ad Opieki Zdrowotnej Reumatologia   (Poland)

^f Movetis NV   (Belgium)

^g Shire Pharmaceuticals   (United Kingdom)

^h SHIRE   (United States)

Author keywords

Clinical trial; Constipation; Long term; Prucalopride

Indexed keywords

PLACEBO; PRUCALOPRIDE; BENZOFURAN DERIVATIVE; SEROTONIN 4 AGONIST;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BEHAVIOR DISORDER; CEREBROVASCULAR ACCIDENT; CHRONIC CONSTIPATION; COLONOSCOPY; CONTROLLED STUDY; DEFECATION HABIT; DEPRESSED BLOOD PRESSURE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; FEMALE; HUMAN; LONG TERM CARE; MALE; MOVEMENT (PHYSIOLOGY); MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT ASSESSMENT; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; QT PROLONGATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SECONDARY ANALYSIS; SENSITIVITY ANALYSIS; STOMACH OBSTRUCTION; CHRONIC DISEASE; CLINICAL TRIAL; CONSTIPATION; LONGITUDINAL STUDY; MIDDLE AGED; TREATMENT OUTCOME;

ADULT; AGED; BENZOFURANS; CHRONIC DISEASE; CONSTIPATION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; SEROTONIN 5-HT4 RECEPTOR AGONISTS; TREATMENT OUTCOME;

EID: 84929654260     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/nmo.12553     Document Type: Article

References (16)

1. Choung RS, Locke GR 3rd, Rey E, Schleck CD, Baum C, Zinsmeister AR, Talley NJ. Factors associated with persistent and nonpersistent chronic constipation, over 20 years. Clin Gastroenterol Hepatol 2012; 10: 494-500.
2. Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther 2007; 25: 599-608.
3. Muller-Lissner S, Tack J, Feng Y, Schenck F, Specht Gryp R. Levels of satisfaction with current chronic constipation treatment options in Europe - an internet survey. Aliment Pharmacol Ther 2013; 37: 137-45.
4. Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil 2010; 22: 991-8.
5. Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut 2009; 58: 357-65.
6. Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med 2008; 358: 2344-54.
7. Quigley EM, Vandeplassche L, Kerstens R, Ausma J. 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. Aliment Pharmacol Ther 2009; 29: 315-28.
8. Tack J, Quigley E, Camilleri M, Vandeplassche L, Kerstens R. Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis. United European Gastroenterol J 2013; 1: 48-59.
9. Ke M, Zou D, Yuan Y, Li Y, Lin L, Hao J, Hou X, Kim HJ. Prucalopride in the treatment of chronic constipation in patients from the Asia-Pacific region: a randomized, double-blind, placebo-controlled study. Neurogastroenterol Motil 2012; 24: 999-e541.
10. Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. 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; 32: 1113-23.
11. ICH harmonised tripartite guidelines for good clinical practice 1996. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (Accessed 14 August 2014).
12. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/ (cited 14 August 2014).
13. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997; 32: 920-4.
14. Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol 1999; 34: 870-7.
15. Dubois D, Gilet H, Viala-Danten M, Tack J. Psychometric performance and clinical meaningfulness of the Patient Assessment of Constipation-Quality of Life questionnaire in prucalopride (RESOLOR) trials for chronic constipation. Neurogastroenterol Motil 2010; 22: e54-63.
16. Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol 2005; 40: 540-51.