A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia

Neurogastroenterology and Motility

Volumn 21, Issue 3, 2009, Pages 272-280

  Tack, J ^a   Masclee, A ^b   Heading, R ^c   Berstad, A ^d   Piessevaux, H ^e   Popiela, T ^f   Vandenberghe, A ^g   Kato, H ^h  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

^d HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^e CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^f JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^g R and D   (Belgium)

^h ZERIA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Acotiamide; Functional dyspepsia; Gastric accommodation; Gastric emptying; Gastric sensitivity; Z 338

Indexed keywords

ACOTIAMIDE; GASTROINTESTINAL AGENT; N [2 (DIISOPROPYLAMINO)ETHYL] 2 (2 HYDROXY 4,5 DIMETHOXYBENZAMIDO) 4 THIAZOLECARBOXAMIDE; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ANGINA PECTORIS; ARTICLE; BAROSTAT; BILIARY COLIC; BLOATING; BREATH ANALYSIS; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; FUNCTIONAL DISEASE; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; STOMACH DISTENSION; STOMACH EMPTYING;

ADOLESCENT; ADULT; AGED; BENZAMIDES; BREATH TESTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DYSPEPSIA; FEMALE; GASTRIC EMPTYING; GASTROINTESTINAL AGENTS; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PLACEBOS; QUALITY OF LIFE; THIAZOLES; YOUNG ADULT;

EID: 60649100914     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/j.1365-2982.2009.01261.x     Document Type: Article

References (32)

1. Tack J, Talley NJ, Camilleri M et al. Functional gastroduodenal disorders. Gastroenterology 2006 130 : 1466 79.
2. Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada J-R, Tytgat GJN. Functional gastroduodenal disorders. Gut 1999 45 (Suppl. II 37 42.
3. Tack J, Caenepeel P, Fischler B, Piéssevaux H, Janssens J. Symptoms associated with hypersenstivity to gastric distention in functional dyspepsia. Gastreonterology 2001 121 : 526 35.
4. Tack J, Piéssevaux H, Coulie B, Caenepeel P, Janssens J. Role of impaired gastric accommodation to a meal in functional dyspepsia. Gastroenterology 1998 115 : 1346 52.
5. Kim DY, Delgado-Aros S, Camilleri M et al. Non invasive measurement of gastric accommodation in patients with idiopathic non ulcer dyspepsia. Am J Gastroenterol 2001 96 : 3099 105.
6. Sarnelli G, Caenepeel P, Geypens B, Janssens J, Tack J. Symptoms associated with impaired gastric emptying of solids and liquids in functional dyspepsia. Am J Gastroenterol 2003 98 : 783 8.
7. Stanghellini V, Tosetti C, Paternic A et al. Risk indicators of delayed gastric emptying of solids in patients with functional dyspepsia. Gastroenterology 1996 110 : 1036 42.
8. Maes BD, Ghoos YF, Hiele MI, Rutgeerts PJ. Gastric emptying rate of solids in patients with non ulcer dyspepsia. Dig Dis Sci 1997 42 : 1158 62.
9. Mertz H. Role of the brain and the sensory pathways in gastrointestinal sensory disorders in humans. Gut 2002 51 (Suppl. I i29 33.
10. Tack J, Bisschops R, DeMarchi B. Causes and treatment of functional dyspepsia. Curr Gastroenterol Rep 2001 3 : 503 8.
11. Mearin F, Cucala M, Azpiroz F, Malagelada JR. The origin of symptoms on the brain-gut axis in functional dyspepsia. Gastroenterology 1991 101 : 999 1006.
12. Wilmer A, Van Cutsem E, Andrioli A, Tack J, Coremans G, Janssens J. Ambulatory gastrojejunal manometry in severe motility-like dyspepsia: lack of correlation between dysmotility, symptoms and gastric emptying. Gut 1998 42 : 36 41.
13. 4 receptors. Gastroenterology 1999 116 (4 part 2 A1094.
14. Seto K., Sasaki T., Katsunuma K., Kobayashi N., Tanaka K., Tack J. Z-338, a novel gastroprokinetic agent, restores delayed gastric emptying and feeding inhibition induced by restraint stress in rats. Neurogastroenterol Motil 2008 20 : 1051 9.
15. Doi Y, Murasaki O, Kaibara M et al. Characterization of functional effect of Z-338, a novel gastroprokinetic agent, on the muscarinic M1, M2, and M3 receptors expressed in Xenopus oocytes. Eur J Pharmacol 2004 505 : 31 5.
16. Matsunaga Y, Ueki S, Matsumura T et al. A novel gastroprokinetic agent stimulates gastrointestinal motor activity and improves delayed gastric emptying in the dog and the rat. Jpn J Pharmacology 1998 76 (Suppl. 1 290.
17. Ueki S, Yoshida K, Eta R et al. In vitro pharmacological profile of Z-338, a novel prokinetic agent. Jpn J Pharmacology 1998 76 (Suppl. 1 290.
18. Nakajima T, Nawata H, Ito Y. Z-338, a newly synthetised carboxyamide derivative, stimulates gastric motility through enhancing excitatory neurotransmission. J Smooth Muscle Res 2000 36 : 69 81.
19. Ogishima M, Kaibara M, Ueki S, Kurimoto T, Taniyama K. Z-338 facilitates acetylcholine release from enteric neurons due to blockade of muscarinic auto-receptors in guinea pig stomach. J Pharmacol Exp Ther 2000 294 : 33 7.
20. Oliver SD, Ward C, Ward J, Kato H, Saito Y, Furuta S. Z-338: Phase I, single and multiple oral dose, safety, tolerability and pharmacokinetic studies in healthy male subjects. Abstracts of the Joint Meeting of VII World Conference on Clinical Pharmacology and Therapeutics IUPHAR - Division of Clinical Pharmacology & 4th Congress of the European Association for Clinical Pharmacology and Therapeutics. Florence, Italy : CPT2000, 2000 : p. 244.
21. Prather CM, Camilleri M, Zinsmeister AR, McKinzie S, Thomforde G. Tegaserod accelerates orocecal transit in patients with constipation-predominant irritable bowel syndrome. Gastroenterology 2000 118 : 463 8.
22. Kim YS, Kim TH, Choi CS et al. Effect of itopride, a new prokinetic, in patients with mild GERD: a pilot study. World J Gastroenterol 2005 11 : 4210 4.
23. Tack J, Middleton SJ, Horne MC et al. Pilot study of the efficacy of renzapride on gastrointestinal motility and symptoms in patients with constipation-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2006 23 : 1655 65.
24. Coulie B, Tack J, Maes B, Geypens B, De Roo M, Janssens J. Sumatriptan, a selective 5-HT1 receptor agonist, induces a lag phase for gastric emptying of liquids in humans. Am J Physiol 1997 272 (4 Pt 1 G902 8.
25. Whitehead WE, Delvaux M. Standardisation of procedures for testing smooth muscle tone and sensory thresholds in the gastrointestinal tract. Dig Dis Sci 1997 42 : 223 41.
26. Notival R, Coffin B, Aspiroz F, Mearin F, Serra J, Malagelada JR. Gastric tones determines the sensitivity of the stomach distension. Gastroenterology 1995 108 : 330 6.
27. Haycock G, Schwartz G, Witotsky D. Geometric method fro measuring body surface area. J Pediatr 1978 93 : 62 6.
28. Ghoos YF, Maes BD, Geypens BJ et al. Measurement of gastric emptying rate of solids by means of a carbon labelled octanoïc acid breath test. Gastroenterology 1993 104 : 1640 7.
29. Maes BD, Ghoos YF, Geypens BJ et al. Combined carbone-13-glycine/carbon- 14-octanoïc acid breath test to monitor gastric emptying rates of liquids and solids. J Nucl Med 1994 35 : 824 31.
30. Maes BD, Ghoos YF, Geypens BJ, Mys G, Evenepoel P, Rutgeerts PJ. Gastric emptying flow curves separated from carbon labelled octanoïc acid breath test results. Am J Physiol 1998 275 : G169 75.
31. QualityMetric Incorporated. SF-36 Health Survey. Lincoln, RI : Quality Metric Incorporated and Medical Outcomes Trust, 1996.
32. Matsueda K, Hongo M, Sasaki D et al. Therapeutic efficacy of novel agent (Z-338) in functional dyspepsia. Gastroenterology 2004 128 : A456. (abstract).