TZP-102 in diabetic gastroparesis

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP-102 for the Treatment of Symptomatic Gastroparesis in Patients with Diabetes Mellitus.

• IRAS ID

  28237

• Contact name

  Rayaz Malik

• Sponsor organisation

  Tranzyme Incorporated

• Eudract number

  2008-007226-19

• ISRCTN Number

  n/a

• Research summary

  Gastroparesis is a disorder characterised by symptoms of and evidence for gastric retention in the absence of mechanical obstruction. Symptoms include nausea, vomiting and abdominal discomfort and it is estimated that up to 4% of the US population experience symptoms of this condition. Diabetes mellitus is the most common systemic disease associated with gastroparesis and the pharmaceutical company Tranzyme, Inc. has developed a new orally-administered drug TZP-102 which has been developed for the treatment of symptomatic gastroparesis. The main objective of this study is to evaluate the effect of TZP-102 on gastric emptying rate in patients with gastroparesis due to diabetes mellitus. The study will assess 3 dosage levels of TZP-102 (10mg, 20mg and 40mg) administered once daily for 28 days. Up to 80 male and female patients with type 1 or type 2 diabetes mellitus, aged between 18 and 80 and having been diagnosed with gastroparesis will be enrolled subject to satisfying all inclusion criteria. Patients will be randomly assigned to one of the three dosages of TZP-102 or to a placebo (inactive treatment). During the study patients will be required to visit the hospital a total of 8 times over the study period of approximately 10 -11 weeks. During these visits patients will be required to give a full medical history, undergo physical examinations and ECGs (electrocardiograms), complete questionnaires, give blood and urine samples and undergo breath tests to measure gastric emptying rate.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  09/H0906/77

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Further Information Favourable Opinion