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

Alimentary Pharmacology and Therapeutics

Volumn 32, Issue 9, 2010, Pages 1113-1123

  Camilleri, M ^a   Van Outryve, M J ^b   Beyens, G ^c   Kerstens, R ^c   Robinson, P ^d   Vandeplassche, L ^c  

^a MAYO CLINIC   (United States)

^b ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^c Movetis NV   (Belgium)

^d Rocky Top Pharmaceutical Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LAXATIVE; PLACEBO; PRUCALOPRIDE;

ABDOMINAL PAIN; ADULT; ARTICLE; CHRONIC DISEASE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEADACHE; HUMAN; INTESTINE FUNCTION; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PSYCHOMETRY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BENZOFURANS; CHRONIC DISEASE; CONSTIPATION; DEFECATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; LAXATIVES; MALE; MIDDLE AGED; PILOT PROJECTS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEROTONIN 5-HT4 RECEPTOR AGONISTS; STATISTICS AS TOPIC; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 78649484435     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2010.04455.x     Document Type: Article

References (31)

1. Bracco A, Kahler K. Burden of chronic constipation must include estimates of work productivity and activity impairment in addition to traditional healthcare utilization. Am J Gastroenterol 2004; 99(Suppl. 10): S233.
2. Irvine EJ, Ferrazzi S, Pare P, Thompson WG, Rance L. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol 2002; 97: 1986-93.
3. Chang L. Review article: epidemiology and quality of life in functional gastrointestinal disorders. Aliment Pharmacol Ther 2004; 20(Suppl. 7): 31-9.
4. Glia A, Lindberg G. Quality of life in patients with different types of functional constipation. Scand J Gastroenterol 1997; 32: 1083-9.
5. Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in Canada: definitions, rates, demographics, and predict tors of health care seeking. Am J Gastroenterol 2001; 96: 3130-7.
6. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004; 99: 750-9.
7. Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther 2007; 25: 599-608.
8. Tack J, Dubois D, Schenk F. Only 27% of patients with chronic constipation are satisfied with current treatment options. Gut 2009; 58(Suppl. II): A181.
9. Dinning PG, Szczesniak MM, Cook IJ. Proximal colonic propagating pressure waves sequences and their elationship with movements of content in the proximal human colon. Neurogastroenterol Motil 2008; 20: 512-20.
10. Bassotti G, Gaburri M, Imbimbo BP, et al. Colonic mass movements in idiopathic chronic constipation. Gut 1988; 29: 1173-9.
11. Crowell MD, Bassotti G, Cheskin LJ, Schuster MM, Whitehead WE. Method for prolonged ambulatory monitoring of high-amplitude propagated contractions from colon. Am J Physiol 1991; 261(2 Pt1): G263-8.
12. Bassotti G, Chistolini F, Nzepa FS, Morelli A. Colonic propulsive impairment in intractable slow-transit constipation. Arch Surg 2003; 138: 1302-4.
13. Rao SS, Sadeghi P, Beaty J, Kavlock R. Ambulatory 24-hour colonic manometry in slow-transit constipation. Am J Gastroenterol 2004; 99: 2405-16.
14. Stivland T, Camilleri M, Vassallo M, et al. Scintigraphic measurement of regional gut transit in idiopathic constipation. Gastroenterology 1991; 101:107-15.
15. 4 receptor agonists: similar but not the same. Neurogastroenterol Motil 2008; 20: 99-112.
16. Briejer MR, Prins NH, Schuurkes JA. Effects of the enterokinetic prucalopride (R093877) on colonic motility in fasted dogs. Neurogastroenterol Motil 2001; 13: 465-72.
17. Briejer MR, Bosmans JP, Van Daele P, et al. The in vitro pharmacological profile of prucalopride, a novel enterokinet compound. Eur J Pharmacol 2001; 423: 71-83.
18. 4 receptor agonist, prucalopride, on colonic motility in healthy volunteers. Aliment Pharmacol Ther 2002; 16: 603-12.
19. 4 agonist, prucalopride, in healthy humans. Gut 1999; 44: 682-6.
20. Bouras EP, Camilleri M, Burton DD, Thomforde G, McKinzie S, Zinsmeister AR. Prucalopride accelerates gastrointestinal and colonic transit in patients with constipation without a rectal evacuationdisorder. Gastroenterology 2001; 120:354-60.
21. Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med 2008; 29: 358.
22. 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, placebocontrolled study. Aliment Pharmacol Ther 2009; 29: 315-28.
23. 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.
24. Camilleri M, Specht-Gryp R, Kerstens R, Vandeplassche L. Efficacy of 12-week treatment with prucalopride (Resolor®) in patients with chronic constipation:combined results of three identical randomized, double-blind, placebo-controlled phase III trials [Abstract 1402]. Gastroenterology 2008; 134: A548.
25. 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.
26. 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.
27. Resolor (prucalopride). Summary of product characteristics. Available at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/resolor/H-1012-PI-en.pdf.
28. McCallum IJ, Ong S, Mercer-Jones M. Chronic constipation in adults. BMJ 2009; 338: b831.
29. Peppas G, Alexiou VG, Mourtzoukou E, Falagas ME. Epidemiology of constipation in Europe and Oceania: a systematic review. BMC Gastroenterol 2008; 8: 5.
30. Stewart WF, Liberman JN, Sandler RS, et al. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol 1999; 94: 3530-40.
31. Wald A, Scarpignato C, Mueller-Lissner S, et al. A multinational survey of prevalence and patterns of laxative use among adults with self-defined constipation. Aliment Pharmacol Ther 2008; 28: 917-30.