Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tranzyme, Inc.

Criteria

Inclusion Criteria:

• 18 to 80 years of age inclusive

• Type 1 or type 2 diabetes mellitus

• History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit

• Documented delayed gastric emptying

• Upper gastrointestinal obstruction ruled out by endoscopy or barium scan

• Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.

• Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception

Exclusion Criteria:

• Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty

• Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study

• NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit

• Required parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit

• Active gastric pacemaker within 3 months prior to the Screening Visit