A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia

Gut

Volumn 61, Issue 6, 2012, Pages 821-828

  Matsueda, Kei ^a   Hongo, Michio ^b   Tack, Jan ^c   Saito, Youichi ^d   Kato, Hiroki ^d  

^a Sakura Life Clinic   (Japan)

^b TOHOKU UNIVERSITY HOSPITAL   (Japan)

^c UNIVERSITY OF LEUVEN   (Belgium)

^d ZERIA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ACOTIAMIDE; PLACEBO;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BLOATING; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; EPIGASTRIC FULLNESS; FEMALE; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HUMAN; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PATIENT ASSESSMENT; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SATIETY; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL; VOMITING;

ADULT; BENZAMIDES; CHOLINESTERASE INHIBITORS; DOUBLE-BLIND METHOD; DYSPEPSIA; EATING; FEMALE; HUMANS; MALE; POSTPRANDIAL PERIOD; THIAZOLES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84859855819     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2011-301454     Document Type: Article

References (46)

1. Drossman DA, Corazziari E, Delvaux M, et al. Rome III: The Functional Gastrointestinal Disorders. 3rd edn. McLean, VA: Degnon Associates, Inc., 2006.
2. Stanghellini V. Three-Month Prevalence Rates of Gastrointestinal Symptoms and the Influence of Demographic Factors: Results from the Domestic/ International Gastroenterology Surveillance Study (DIGEST). Scand J Gastroenterol Suppl 1999;231:20-8. (Pubitemid 29510674)
3. Kawamura A, Adachi K, Takashima T, et al. Prevalence of functional dyspepsia and its relationship with Helicobacter pylori infection in a Japanese population. J Gastroenterol Hepatol 2001;16:384-8. (Pubitemid 32397649)
4. Okumura T, Tanno S, Ohhira M, et al. Prevalence of functional dyspepsia in an outpatient clinic with primary care physicians in Japan. J Gastroenterol 2010;45:187-94.
5. Nakajima S. The spectra of functional gastrointestinal disorders (FGID) in a Japanese hospital outpatient department according to the ROME II Integrative Questionnaire. J Gastroenterol Hepatol 2008;23(Suppl 2):S186-92.
6. Brook RA, Kleinman NL, Choung RS, et al. Functional dyspepsia impacts absenteeism and direct and indirect costs. Clin Gastroenterol Hepatol 2010;8:498-503.
7. Talley NJ, Vakil NB, Moayyedi P. American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology 2005;129:1756-80. (Pubitemid 41597412)
8. Tack J, Talley NJ, Camilleri M, et al. Functional gastroduodenal disorders. Gastroenterology 2006;130:1466-79.
9. Tack J, Janssen P. Acotiamide (Z-338, YM443), a new drug for the treatment of functional dyspepsia. Expert Opin Investig Drugs 2011;20:701-12.
10. Ogishima M, Kaibara M, Ueki S, et al. Z-338 facilitates acetylcholine release from enteric neurons due to blockade of muscarinic autoreceptors in guinea pig stomach. J Pharmacol Exp Ther 2000;294:33-7. (Pubitemid 30434667)
11. Nakajima T, Nawata H, Ito Y. Z-338 a newly synthesized carboxyamide derivative, stimulates gastric motility through enhancing the excitatory neurotransmission. J Smooth Muscle Res 2000;36:69-81.
12. Seto K, Sasaki T, Katsunuma K, et al. Acotiamide hydrochloride (Z-338), a novel prokinetic agent, restores delayed gastric emptying and feeding inhibition induced by restraint stress in rats. Neurogastroenterol Motil 2008;20:1051-9.
13. Matsueda K, Hongo M, Tack J, et al. Clinical trial: dose-dependent therapeutic efficacy of acotiamide hydrochloride (Z-338) in patients with functional dyspepsia 100mg t.i.d. is an optimal dosage. Neurogastroenterol Motil 2010;22:618-27.
14. Tack J, Masclee A, Heading R, et al. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil 2009;21:272-80.
15. Talley N, Tack J, Kowalski D, et al. A novel acetylcholine esterase inhibitor acotiamide hydrochloride (YM443) in functional dyspepsia: efficacy in a randomized, double-blind, placebo-controlled dose ranging trial. Gastroenterology 2008;134:A157.
16. Tack J, Talley N, Kowalski D, et al. Influence of PPI run-in, pH monitoring and nutrient tolerance on efficacy outcomes of acotiamide hydrochloride (YM443), a novel acetylcholine esterase inhibitor, in functional dyspepsia. Gastroenterology 2008;134:16.
17. Ang D, Talley NJ, Simren M, et al. Endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther 2011;33:634-49.
18. Guyatt GH, Townsend M, Berman LB, et al. A comparison of Likert and Visual Analogue Scales for measuring change in function. J Chronic Dis 1987;40:1129-33. (Pubitemid 17158144)
19. Veldhuyzen van Zanten SJ, Jones MJ, Verlinden M, et al. Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia: a meta-analysis. Am J Gastroenterol 2001;96:689-96. (Pubitemid 32240716)
20. Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, et al. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996;91:660-73. (Pubitemid 26117940)
21. Chiba N, Van Zanten SJ, Sinclair P, et al. Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: The Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-HP) randomised controlled trial. BMJ 2002;324:1012-16. (Pubitemid 34457514)
22. Armstrong D, Veldhuyzen van Zanten SJ, Barkun AN, et al; the CADET-HR Study Group. Heartburn-dominant, uninvestigated dyspepsia: a comparison of 'PPI-Start' and 'H2-RA-Start' management strategies in primary care. The CADET-HR Study. Aliment Pharmacol Ther 2005;21:1189-202. (Pubitemid 40733484)
23. Van Zanten SJ, Armstrong D, Chiba N, et al. Esomeprazole 40 mg once a day in patients with functional dyspepsia: The Randomized, Placebo-Controlled "ENTER" Trial. Am J Gastroenterol 2006;101:2096-106. (Pubitemid 44337636)
24. Vakil N, Laine L, Talley NJ, et al. Tegaserod treatment for functional dyspepsia dysmotility symptoms: results of two randomized, controlled trials. Am J Gastroenterol 2008;103:1906-19.
25. Talley NJ, Verlinden M, Jones M. Validity of a new quality of life scale for functional dyspepsia: a United states multicenter trial of the Nepean Dyspepsia Index. Am J Gastroenterol 1999;94:2390-7. (Pubitemid 29420662)
26. Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and development of a new-10 item short form. Aliment Pharmacol Ther 2001;15:207-16. (Pubitemid 32142498)
27. Burke LB, Kennedy DL, Miskala PH, et al. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther 2008;84:281-3.
28. Trentacosti AM, He R, Burke LB, et al. Evolution of clinical trials for irritable bowel syndrome: issues in end points and study design. Am J Gastroenterol 2010;105:731-5.
29. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN study. Am J Gastroenterol 2005;100:1477-88. (Pubitemid 41032350)
30. Blum AL, Talley NJ, O'Morain C, et al. Lack of effect of treating Helicobacter pylori infection in patients with nonulcer dyspepsia. Omeprazole plus Clarithromycin and Amoxicillin Effect One Year after Treatment (OCAY) Study Group. N Engl J Med 1998;339:1875-81.
31. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989;10:407-15. (Pubitemid 20025670)
32. Fass R, Tougas G. Functional heartburn: the stimulus, the pain and the brain. Gut 2002;51:885-92. (Pubitemid 35408615)
33. Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guideline for the management of dyspepsia. Am J Gastroenterol 2005;100:2324-37.
34. Hallerback BI, Bommelaer G, Bredberg E, et al. Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study. Aliment Pharmacol Ther 2002;16:959-67. (Pubitemid 34461766)
35. Holtmann G, Talley NJ, Liebregts T, et al. A placebo-controlled trial of Itopride in functional dyspepsia. N Engl J Med 2006;354:832-40. (Pubitemid 43290921)
36. Talley NJ, Tack J, Ptak T, et al. Itopride in functional dyspepsia: results of two Phase III multicentre, randomised, double-blind, placebo-controlled trials. Gut 2008;57:740-6. (Pubitemid 351716964)
37. Tack J, Delia T, Ligozio G, et al. A Phase II placebo controlled randomized trial with tegaserod in functional dyspepsia patients with normal gastoric emptying. Gastroenterology 2002;122:154.
38. Halder SL, Talley NJ. Functional Dyspepsia: A new Rome III Paradigm. Curr Treat Options Gastroenterol 2007;10:259-72. (Pubitemid 47193510)
39. Corazziari E, Bytzer P, Delvaux M, et al. Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmacol Ther 2003;18:569-80. (Pubitemid 37186606)
40. Jones M, Talley NJ. Minimum clinically important difference for the Nepean Dyspepsia Index, a validated quality of life scale for functional dyspepsia. Am J Gastroenterol 2009;104:1483-8.
41. Tonini T, De Ponti F, Di Nucci A, et al. Cardiac adverse effects of gastrointestinal prokinetics. Aliment Pharmacol Ther 1999;13:1585-91. (Pubitemid 30009075)
42. Anon. Tegaserod withdrawal from the world market. A treatment for constipation with cardiovascluar adverse effect. Prescrire Int 2008;17:112-13.
43. De Maeyer JH, Lefebvre RA, Schuurkes JA. 5-HT4 receptor agonists: similar but not the same. Neurogastroenterol Motil 2008;20:99-112.
44. Adam B, Liebregts T, Zschau N, et al. Z-338 improves meal-induced symptoms in Functional Dyspepsia: a double-blind, randomized, placebo controlled crossover study. Gastroenterology 2009;136:A535.
45. Geeraerts B, Van Oudenhove L, Boesmans W, et al. Influence of acute tryptophan depletion on gastric sensorimotor functions in humans. Am J Physiol Gastrointest Liver Physiol 2010;350:G228-35.
46. Geeraerts B, Vndenberghe J, Van Oudenhove L, et al. Influence of experimentally induced anxiety on gastric sensorimotor functions in humans. Gastroenterology 2005;129:1437-44. (Pubitemid 41597386)