Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889486
• Other study ID #: TZP-102-CL-G002
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: December 7, 2012
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: December 2012
• Source: Tranzyme, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencySweden: Medical Products AgencyNorway: Norwegian Medicines AgencyPoland: The Central Register of Clinical TrialsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• 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.

• Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.

• HbA1c level less than/equal to 10.0 % at the Screening Visit.

• Diagnosis of gastroparesis including (all three of the following requirements apply):

i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.

• Upper gastrointestinal obstruction ruled out by endoscopy or barium scan.

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

• Body Mass Index (BMI) < 35.

• Delayed gastric emptying by breath test demonstrated at the Baseline Visit.

Exclusion Criteria:

• Persistent daily vomiting

• Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.

• Pyloric Botox within 6 months prior to Screening Visit.

• NG, PEG or PEJ feeding tube.

• Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.

• 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.

• Participation in an investigational study within 30 days prior to study entry.

• Chronic severe diarrhea.

• Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry.

• History of any eating disorder within 2 years prior to study entry.

• Significant chronic obstructive pulmonary disease or chronic asthma.

• Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed.

• History of risk factors for Torsades de Pointes.

• Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes.

• History of acute myocardial infarction (MI) or unstable angina within 12 months prior to study entry.

• History of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.

• History of alcohol dependency within 2 years prior to study entry.

• Taking opiates for abdominal pain.

• History of HIV infection.

• History of Hepatitis B or C currently exhibiting symptoms expected to worsen during course of study.

• Requires dialysis or has severely impaired renal function.

• Severe impairment of liver function.

• Uncontrolled hypo- or hyperthyroidism.

• History of adrenal insufficiency.

• Pregnant or is breast-feeding.

• Allergic to or intolerant of wheat, egg, soy or milk products.

• Patient requires a gluten-free diet.

• Any other medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

Drug:
• TZP-102

• Placebo

Locations

Country	Name	City	State
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Steno Diabetes Center	Gentofte
Denmark	Odense University Hospital	Odense
Norway	Haukeland University Hospital	Bergen
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad	Lodz
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warsaw
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	Ipswich Hospital NHS Trust	Ipswich
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Wellcome Truest Clinical Research Facility	Manchester
United States	Saint John's Research Institute	Anderson	Indiana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Texas Tech Univ. Health Sciences Center Dept. of Medicine	El Paso	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Long Beach VA Medical Center	Long Beach	California
United States	Impact Clinical Trials	Los Angeles	California
United States	Univ. of Louisville Medical-Dental Complex	Louisville	Kentucky
United States	Wake Research Associates	Raleigh	North Carolina
United States	California Pacific Medical Center Research Institute	San Francisco	California
United States	University of South Florida/Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tranzyme, Inc.

Countries where clinical trial is conducted

United States,  Denmark,  Norway,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in gastric half-emptying time		study days 1 and 28	No
Secondary	change from baseline in gastroparesis symptoms and health-related quality of life		study days 8, 15 and 28	No