April 27, 2009
Tranzyme released positive results from a phase II trial of TZP-101 for the treatment of gastroparesis. This double-blind, placebo controlled study enrolled 76 subjects with either type I or type II diabetes mellitus and a confirmed diagnosis of gastroparesis, in the US and Europe. Subjects were randomized to receive a daily 30-minute intravenous infusion of one of six doses of TZP-101 (20-600 I 0.25g/kg) or placebo for four consecutive days. Efficacy was evaluated by symptom improvement as assessed by both the patients and study investigators, measured via the Gastroparesis Cardinal Symptom Index (GCSI), meal-related Gastroparesis Symptom Assessment (GSA) and Clinician Rated Symptom Assessment (CRSA) scores. Maximum clinical benefit was observed with the 80 I 0.25g/kg dose of TZP-101. At day four, improvement in symptoms in TZP-101-treated subjects was statistically significant over placebo-treated subjects for the following symptoms: vomiting (p≡0.006), loss of appetite (p≡0.034), postprandial fullness (p≡0.007), early satiety (p≡0.087), abdominal distension (p≡0.053) and bloating (p≡0.0822). Statistical significance was also observed by the CRSA Overall Symptom scores (p≡0.046). The 30-day follow-up evaluation demonstrated a sustained benefit in symptom improvement; this effect reached statistical significance for vomiting (p≡0.023). TZP-101 was safe and well tolerated at all doses.
August 18, 2003
Medtronic reported positive results from a phase I/II trial investigating Enterra Therapy, a gastric electrical stimulator for the treatment of gastroparesis. Results showed the treatment significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in subjects with severe gastroparesis. The randomized, double blind study enrolled 33 subjects with chronic gastroparesis who were unresponsive to standard medical therapy. Subjects received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. Results were reported in the August 2003 issue of Gastroenterology.