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Randomised clinical trial: ghrelin agonist TZP-101 relieves gastroparesis associated with severe nausea and vomiting - randomised clinical study subset data
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. (Gastroenterologi/Hellström)
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2011 (English)In: Alimentary Pharmacology and Therapeutics, ISSN 0269-2813, E-ISSN 1365-2036, Vol. 33, no 6, 679-688 p.Article in journal (Refereed) Published
Abstract [en]


Limited therapeutic options exist for severe gastroparesis, where severe nausea and vomiting can lead to weight loss, dehydration and malnutrition due to inadequate caloric and fluid intake. TZP-101 (ulimorelin) is a ghrelin receptor agonist that accelerates gastric emptying and improves upper gastrointestinal symptoms in diabetic patients with gastroparesis.


To assess effects of TZP-101 in diabetic gastroparesis patients with severe nausea/vomiting and baseline severity scores of >= 3.5 (range: 0-5) on the Gastroparesis Cardinal Symptom Index (GCSI) Nausea/Vomiting subscale.


Patients were hospitalised and received four single daily 30-min infusions of one of six TZP-101 doses (range 20-600 mu g/kg) or placebo. Efficacy was assessed by symptom improvement.


At baseline, 23 patients had a mean severity score for GCSI Nausea/Vomiting of 4.45 +/- 0.44. Statistically significant improvements over placebo occurred in the 80 mu g/kg group for end of treatment changes from baseline in GCSI Nausea/Vomiting subscale (reduction in score of -3.82 +/- 0.76, P = 0.011) and the GCSI Total score (-3.14 +/- 0.78, P = 0.016) and were maintained at the 30-day follow-up assessment (-2.02 +/- 1.63, P = 0.073 and -1.99 +/- 1.33, P = 0.032 respectively). The proportion of days with vomiting was reduced significantly (P = 0.05) in the 80 mu g/kg group (mean of 1.2 days of vomiting for four treatment days) compared with placebo (mean of 3.2 days of vomiting across 4 treatment days).


TZP-101 substantially reduced the frequency and severity of nausea and vomiting as well as overall gastroparesis symptoms. The results are consistent with gastrointestinal motility effects of TZP-101, supporting further investigation of TZP-101 in the management of severe gastroparesis.

Place, publisher, year, edition, pages
2011. Vol. 33, no 6, 679-688 p.
National Category
Gastroenterology and Hepatology
Research subject
Medical Science
URN: urn:nbn:se:uu:diva-148665DOI: 10.1111/j.1365-2036.2010.04567.xISI: 000287361000006PubMedID: 21214610OAI: oai:DiVA.org:uu-148665DiVA: diva2:402638
Available from: 2011-03-09 Created: 2011-03-09 Last updated: 2012-03-15Bibliographically approved

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