Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

Phase 2

Terminated

• Conditions: Diabetic Gastroparesis
• Interventions: Drug: Placebo; Drug: 10 mg TZP-102

• Registration Number: NCT01664637
• Lead Sponsor: Tranzyme, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-01
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo three times a day	Placebo	Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
TZP-102 three times a day	10 mg TZP-102	10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptoms associated with diabetic gastroparesis	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in health-related quality of life	12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters	12 Weeks

Trial Locations

Locations (1)

Tranzyme Investigational Site; 🇵🇱 Zgierz, Poland