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Lupus Clinical Trials

New Medical Therapies™

Diabetic Gastroparesis

August 30, 2010

Tranzyme reported positive results from a phase II trial of TZP-102 for the treatment of gastroparesis in diabetic subjects. This double-blind, placebo-controlled parallel group study enrolled 96 subjects with type I or II diabetes and a confirmed diagnosis of gastroparesis across sites in the U.S. and E.U. The subjects received one of three daily doses of TZP-102 (10, 20 or 40 mg) administered as a single oral dose or placebo, for a treatment period of 28 days. At the end of the treatment period, statistically significant improvements were seen in symptom scores for Nausea, Early Satiety, Excessive Fullness, Postprandial Fullness and total GCSI (Gastroparesis Cardinal Symptom Index), (p≡0.029, 0.001, 0.002, 0.020 and 0.015, respectively). The average severity of symptoms during the 28-day treatment demonstrated similar statistically significant improvements. TZP-102 also improved upper and lower abdominal pain/discomfort (p≡0.025 and p≡.016). At the end of treatment, over 50% of patients on TZP-102 had normalized gastric emptying versus 20% on placebo.

July 5, 2010

Tranzyme reported positive results from a phase II trial of TZP-102 for the treatment of diabetic gastroparesis. This randomized, double-blind, placebo-controlled study enrolled 92 subjects with type I or type II diabetes mellitus and a confirmed diagnosis of gastroparesis. Enrollment took place across the U.S. and Europe. The subjects received one of three daily doses of TZP-102 (10, 20 & 40 mg) administered as a single oral dose or placebo, for a treatment period of 28 days. At the end of the treatment period, statistically significant improvements in symptom scores for Nausea, Early Satiety, Excessive Fullness, Postprandial Fullness and total GCSI (Gastroparesis Cardinal Symptom Index), were observed. The average severity of symptoms during the 28-day treatment demonstrated similar statistically significant improvements. TZP-102 also improved Upper & Lower Abdominal Pain/Discomfort. At the end of treatment, over 50% of the subjects on TZP-102 had normalized gastric emptying, versus 20% on placebo. Improvement in the severity of symptoms was seen within one week of treatment initiation.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.