Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

Diabetic Gastroparesis Clinical Trial

— DIGEST  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01664637
• Other study ID #: TZP-102-CL-G004
• Status: Terminated
• Phase: Phase 2
• First received: August 10, 2012
• Last updated: December 18, 2012
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: December 2012
• Source: Tranzyme, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• 10 mg TZP-102
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
• Placebo
One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks

Locations

Country	Name	City	State
Poland	Tranzyme Investigational Site	Bialystok
Poland	Tranzyme Investigational Site	Bialystok
Poland	Tranzyme Investigational Site	Bydgoszcz
Poland	Tranzyme Investigational Site	Kielce
Poland	Tranzyme Investigational Site	Krakow
Poland	Tranzyme Investigational Site	Lodz
Poland	Tranzyme Investigational Site	Lublin
Poland	Tranzyme Investigational Site	Lublin
Poland	Tranzyme Investigational Site	Olsztyn
Poland	Tranzyme Investigational Site	Rzeszow
Poland	Tranzyme Investigational Site	Warsaw
Poland	Tranzyme Investigational Site	Zgierz
United States	Tranzyme Investigational Site	Anderson	Indiana
United States	Tranzyme Investigational Site	Boston	Massachusetts
United States	Tranzyme Investigational Site	El Paso	Texas
United States	Tranzyme Investigational Site	Hialeah	Florida
United States	Tranzyme Investigational Site	Huntsville	Alabama
United States	Tranzyme Investigational Site	Indianapolis	Indiana
United States	Tranzyme Investigational Site	Inverness	Florida
United States	Tranzyme Investigational Site	Jacksonville	Florida
United States	Tranzyme Investigational Site	Kansas City	Kansas
United States	Tranzyme Investigational Site	Long Beach	California
United States	Tranzyme Investigational Site	Mexico	Missouri
United States	Tranzyme Investigational Site	Miami	Florida
United States	Tranzyme Investigational Site	Miami	Florida
United States	Tranzyme Investigational Site	Monroe	Louisiana
United States	Tranzyme Investigational Site	New Smyrna Beach	Florida
United States	Tranzyme Investigational Site	North Little Rock	Arkansas
United States	Tranzyme Investigational Site	Oklahoma City	Oklahoma
United States	Tranzyme Investigational Site	Portland	Oregon
United States	Tranzyme Investigational Site	Raleigh	North Carolina
United States	Tranzyme Investigational Site	Salisbury	North Carolina
United States	Tranzyme Investigational Site	Tucson	Arizona
United States	Tranzyme Investigational Site	Ventura	California
United States	Tranzyme Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tranzyme, Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in symptoms associated with diabetic gastroparesis		12 Weeks	No
Secondary	Change from baseline in health-related quality of life		12 Weeks	No
Secondary	Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters		12 Weeks	Yes