A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency

Summary

S09A is a Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel study examining the efficacy and safety of a Sucraid (sacrosidase) Oral Solution in comparison to a placebo in 150-200 subjects with chronic diarrhea possibly attributable to sucrase deficiency.

Timeline

Start

2016-05

Primary completion

2017-12

Completion

2017-12

Outcome

Outcome not reported

Stopped: “Clinical Trial Material”

Publications

• Background Arthur AB. Intestinal disaccharidase deficiency in children with coeliac disease. Arch Dis Child. 1966 Oct;41(219):519-24. doi: 10.1136/adc.41.219.519. No abstract available.
• Background Bayless TM, Christopher NL. Disaccharidase deficiency. Am J Clin Nutr. 1969 Feb;22(2):181-90. doi: 10.1093/ajcn/22.2.181.
• Background Chumpitazi BP, Robayo-Torres CC, Tsai CM, Opekun AR, Baker SS, Nichols BL, Gilger MA, Su1110 Yield of prospective disaccharidase testing in children with recurrent abdominal pain. Gastroenterology. May 2013;144(5):S-401-S402.
• Background Cross HS, Quaroni A. Inhibition of sucrose-isomaltase expression by EGF in the human colon adenocarcinoma cells Caco-2. Am J Physiol. 1991 Dec;261(6 Pt 1):C1173-83. doi: 10.1152/ajpcell.1991.261.6.C1173.
• Background Czernichow B, Simon-Assmann P, Kedinger M, Arnold C, Parache M, Marescaux J, Zweibaum A, Haffen K. Sucrase-isomaltase expression and enterocytic ultrastructure of human colorectal tumors. Int J Cancer. 1989 Aug 15;44(2):238-44. doi: 10.1002/ijc.2910440209.
• Background DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med. 1994 Jul 15-30;13(13-14):1341-52; discussion 1353-6. doi: 10.1002/sim.4780131308.
• Background El-Chammas K, Williams S, Miranda A. Su1254 Lactase and sucrase deficiencies in pediatric subjects with chronic abdominal pain. Gastroenterology. May 2014;146(5):S-415-S416.
• Background Gupta SK, Chong SK, Fitzgerald JF. Disaccharidase activities in children: normal values and comparison based on symptoms and histologic changes. J Pediatr Gastroenterol Nutr. 1999 Mar;28(3):246-51. doi: 10.1097/00005176-199903000-00007.
• Background Hatcher RA, Trussell J, Stewart F, Nelson AL, Cates W, Guest F, Kowal DD, editors. Contraceptive Technology. New York: Ardent Media, 2004:226.
• Background Heitlinger LA, Rossi TM, Lee PC, Lebenthal E. Human intestinal disaccharidase activities: correlations with age, biopsy technique, and degree of villus atrophy. J Pediatr Gastroenterol Nutr. 1991 Feb;12(2):204-8.
• Background Hyams JS, Batrus CL, Grand RJ, Sallan SE. Cancer chemotherapy-induced lactose malabsorption in children. Cancer. 1982 Feb 15;49(4):646-50. doi: 10.1002/1097-0142(19820215)49:43.0.co;2-m.
• Background Kerry KR, & Townley, R. R. Genetic aspects of intestinal sucrase-isomaltase deficiency. Australian Paediatric Journal. 1965;1:223.
• Background Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics. 1999 Dec;55(4):1286-90. doi: 10.1111/j.0006-341x.1999.01286.x.
• Background Mones RL, Yankah A, Duelfer D, Bustami R, Mercer G. Disaccharidase deficiency in pediatric patients with celiac disease and intact villi. Scand J Gastroenterol. 2011 Dec;46(12):1429-34. doi: 10.3109/00365521.2011.619276. Epub 2011 Sep 22.
• Background Murray IA, Smith JA, Coupland K, Ansell ID, Long RG. Intestinal disaccharidase deficiency without villous atrophy may represent early celiac disease. Scand J Gastroenterol. 2001 Feb;36(2):163-8. doi: 10.1080/003655201750065915.
• Background Nichols BL Jr, Adams B, Roach CM, Ma CX, Baker SS. Frequency of sucrase deficiency in mucosal biopsies. J Pediatr Gastroenterol Nutr. 2012 Nov;55 Suppl 2:S28-30. doi: 10.1097/01.mpg.0000421405.42386.64. No abstract available.
• Background O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
• Background Osterlund P, Ruotsalainen T, Peuhkuri K, Korpela R, Ollus A, Ikonen M, Joensuu H, Elomaa I. Lactose intolerance associated with adjuvant 5-fluorouracil-based chemotherapy for colorectal cancer. Clin Gastroenterol Hepatol. 2004 Aug;2(8):696-703. doi: 10.1016/s1542-3565(04)00293-9.
• Background Quezada-Calvillo R, Sim L, Ao Z, Hamaker BR, Quaroni A, Brayer GD, Sterchi EE, Robayo-Torres CC, Rose DR, Nichols BL. Luminal starch substrate "brake" on maltase-glucoamylase activity is located within the glucoamylase subunit. J Nutr. 2008 Apr;138(4):685-92. doi: 10.1093/jn/138.4.685.
• Background Reed, JF. (2006) AB/BA Crossover Trials - Binary Outcome. J Modern Applied Stat Methods 5 (2): 452-457.
• Background Treem WR. Clinical aspects and treatment of congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 2012 Nov;55 Suppl 2:S7-13. doi: 10.1097/01.mpg.0000421401.57633.90. No abstract available.
• Background Treem WR, McAdams L, Stanford L, Kastoff G, Justinich C, Hyams J. Sacrosidase therapy for congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 1999 Feb;28(2):137-42. doi: 10.1097/00005176-199902000-00008.
• Background Treem WR. Congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 1995 Jul;21(1):1-14. doi: 10.1097/00005176-199507000-00001. No abstract available.
• Background Treem WR, Ahsan N, Sullivan B, Rossi T, Holmes R, Fitzgerald J, Proujansky R, Hyams J. Evaluation of liquid yeast-derived sucrase enzyme replacement in patients with sucrase-isomaltase deficiency. Gastroenterology. 1993 Oct;105(4):1061-8. doi: 10.1016/0016-5085(93)90950-h.
• Background Uhrich S, Wu Z, Huang JY, Scott CR. Four mutations in the SI gene are responsible for the majority of clinical symptoms of CSID. J Pediatr Gastroenterol Nutr. 2012 Nov;55 Suppl 2:S34-5. doi: 10.1097/01.mpg.0000421408.65257.b5. No abstract available.
• Background Wiecek S, Wos H, Radziewicz Winnicki I, Komraus M, Grzybowska Chlebowczyk U. Disaccharidase activity in children with inflammatory bowel disease. Turk J Gastroenterol. 2014 Apr;25(2):185-91. doi: 10.5152/tjg.2014.3994.

Drugs

Indications