KZE has prepared a broad array of medical, regulatory, and strategic communication products in support of drugs and devices developed for the treatment of gastrointestinal disorders, including irritable bowel syndrome (IBS), gastroparesis, post-operative ileus, functional dyspepsia, and gastroesophageal reflux disease (GERD). Our experience spans a range of therapeutic approaches including novel drugs designed to target multiple disease symptoms, drugs targeting individual symptoms, and devices designed to correct GI dysfunction. Products supported include those targeting the serotonin (5-HT) system, opiate pathways, GLP-1 pathways, ghrelin receptor pathways, and neurokinin pathways.
Medical Writing Products
Peer reviewed clinical trial-based manuscripts
Health outcomes and pharmacoeconomic manuscripts
Medical Information Letters
Clinical trial study reports, protocols, patient-directed communications and
Five-year publication plan for a novel 5-HT3 receptor antagonist for IBS
Secondary and tertiary journal publication plan for a novel 5-HT4 agonist for IBS
Health outcomes publication plan for a novel 5-HT4 agonist for IBS
Publication team management for IBS therapeutic
Environmental Landscape analysis (key themes and issues impacting on development of a publication and communication plan) for a novel opiate agonist for IBS
Competitive analysis (press release activity, publications and meeting abstracts, and other publicly available information such as company web sites to identify product positioning, key milestones and communication strategies for IBS products in development and marketed
IBS training module for sales representatives
Itineraries and summaries for proceedings of international GI meetings
Bibliography: Sample Publications and Abstracts
KD Mullen, AJ. Sayal, NM. Bass, et al., Rifaximin Is Safe and Well Tolerated for Long-term Maintenance of Remission From Overt Hepatic Encephalopathy Clin Gastro Hepatol , pii: S1542-3565(13)01968-X. doi: 10.1016/j.cgh.2013.12.021. [Epub ahead of print] 2014.
F Cremonini, JP Nicandro, V Atkinson, et al. Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS. Aliment Pharmacol Ther 36: 437–448, 2012.
G Bochicchio, P Charlton, JC Pezzullo, et al. Ghrelin Agonist TZP-101/Ulimorelin Accelerates Gastrointestinal Recovery Independently of Opioid Use and Surgery Type: Covariate Analysis of Phase 2 Data. World J Surg (2012) 36:39–45.
PM Hellström,YA Saito, P Bytzer, et al. Characteristics of acute pain attacks in patients with irritable bowel syndrome meeting Rome III criteria. Am J Gastroenterol. 2011 Jul;106(7):1299-307.
JM Wo, NEjskjaer, PM Hellström, et al. Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting randomised clinical study subset data. Aliment Pharmacol Ther. 33(6):679-88, 2011
N Ejskjaer, G Dimcevski, J Wo et al., Safety and efficacy of ghrelin agonist TZP-101 in relieving symptoms in patients with diabetic gastroparesis: a randomized, placebo-controlled study Neurogastoenterol Motility. 22(10):1069-e281, 2010.
L Chang, K Tong, V Ameen. Ischemic colitis and complications of constipation associated with the use of alosetron under a risk management plan: Clinical characteristics, outcomes, and incidences. Am J Gastroenterol 105(4):866-75, 2010.
I Popescu, PR Fleshner, JC Pezullo et al. The ghrelin agonist TZP-101 for management of postoperative ileus after partial colectomy: A randomized, dose-ranging, placebo-controlled clinical trial. Dis Colon Rectum 53(2):126-34, 2010.
W Wargin, H Thomas, L Clohs, C St-Louis, N Ejskjaer, M Gutierrez, L Shaughnessy, G Kosutic Contribution of Protein Binding to the Pharmacokinetics of the Ghrelin Receptor Agonist TZP-101 in Healthy Volunteers and Adults with Symptomatic Gastroparesis: Two Randomized, Double-Blind Studies and a Binding Profile Study. Clin Drug Investig 29: 409-18, 2009.
N Ejskjaer, ET Vestergaard, PM Hellström et al. Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. Aliment Pharm Ther 29: 1179–1187, 2009.
PM Hellström, J Hein, P Bytzerm et al. Clinical Trial: The GLP-1 analogue ROSE-010 for management of acute pain in patients with irritable bowel syndrome: a randomised, placebo-controlled, double-blind study. Aliment Pharm Ther 29:198-206, 2009.
R Krause, V Ameen MD, S Gordon, et al. Randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5mg and 1mg alosetron in women with severe diarrhea-predominant IBS. Am J Gastroenterology 102(8):1709-19, 2007.
VZ Ameen, BF Pobiner, GC Giguere, and EG Carter. Ranitidine (Zantac) syrup versus ranitidine effervescent tablets (Zantac EFFERdose) in children: a single-center taste preference study. Pediatric Drugs 8(4):265-70, 2006.
The Functional Gastrointestinal Disorders, 3rd Edition. S Drossman, Sr. Ed. Maclean, Va: Degnan Associates. 2006 (content editor)
DA Johnson. Enteryx implant for gastroesophageal reflux disease. Curr Treat Opt Gastroenterol 8: 51-57, 2005.
K Koch, C Campanella, CA Baidoo, et al. Pharmacodynamics and pharmacokinetics of oral contraceptives co-administered with alosetron (Lotronex). Dig Dis Sci. 49:1244-9, 2004.
S Gordon, V Ameen, B Bagby, et al. Validation of the Irritable Bowel Syndrome Global Improvement Scale: An Integrated Symptom Endpoint for Assessing Treatment Efficacy. Dig Dis Sci 48(7):1317-23, 2003.
T Lembo, RA Wright, B Bagby, et al. Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol. 96(9):2662-70, 2001.
M Camilleri, WY Chey, EA Mayer, et al. A randomize, controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Int Med. 161: 1733-40, 2001.
NJ Talley, S Veldhuyzen van Zanten, G Dukes, et al, Dose-ranging, randomized, placebo-controlled, clinical trial of alosetron in subjects with functional dyspepsia Aliment Pharm Therapeutics: 15(4):525-37, 2001.
SG Wolfe, WY Chey, MK Washington, et al. Tolerability and safety of alosetron during long-term administration in female and male IBS patients, Am J Gastroenterology: 96(3):803-11, 2001.
NJ Talley, S Kong, PC Ferriola, AW Mangel Demographic and clinical characteristics of nonconstipated female IBS patients in the United States NJ Gastroenterology 118(4):A147, 2000.
JF Ricci, P Jhingran, T McLaughlin, E Carter. Costs of Care for Irritable Bowel Syndrome in Managed Care. J Clin Outcomes Management, 7: 23-28, 2000.
M Camilleri, AR Northcutt, S Kong, et al. The efficacy and safety of alosetron in female patients with irritable bowel syndrome: a randomized, placebo controlled study. Lancet, 225:1035-40, 2000.
R Jones, G Holtmann G, L Rodrigo, et al. Alosetron relieves pain and improves bowel function compared with mebeverine in female nonconstipated irritable bowel syndrome patients. Aliment Pharm Ther, 13: 1419-1427, 1999.
PJ Horvath, PC Ferriola, MM Weiser, and ME Duffey, Localization of chloride secretion in the rabbit colon by inhibition with A-9-C. Am. J. Physiol. 250:G185-190, 1986.
PC Ferriola, MA Acara, and ME Duffey. Thiazide diuretics inhibit chloride absorption across rabbit colon. J. Pharmacol. Exp. Ther. 238:912-915, 1986.