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

Sponsor

Tranzyme, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00889486

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Diabetes Mellitus	Drug: TZP-102 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Four placebo capsules taken orally once per day for 28 days	Drug: Placebo
Experimental: 10 mg TZP-102 One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days	Drug: TZP-102 Drug: Placebo
Experimental: 20 mg TZP-102 Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days	Drug: TZP-102 Drug: Placebo
Experimental: 40 mg TZP-102 Four 10 mg TZP-102 Capsules taken orally once per day for 28 days	Drug: TZP-102

Outcome Measures

Primary Outcome Measures

change from baseline in gastric half-emptying time [study days 1 and 28]

Secondary Outcome Measures

change from baseline in gastroparesis symptoms and health-related quality of life [study days 8, 15 and 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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):

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach VA Medical Center	Long Beach	California	United States	90822
2	Impact Clinical Trials	Los Angeles	California	United States	90036
3	California Pacific Medical Center Research Institute	San Francisco	California	United States	94115
4	University of South Florida/Tampa General Hospital	Tampa	Florida	United States	33606
5	Saint John's Research Institute	Anderson	Indiana	United States	46012
6	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
7	Univ. of Louisville Medical-Dental Complex	Louisville	Kentucky	United States	40202
8	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
9	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
10	Wake Research Associates	Raleigh	North Carolina	United States	27612
11	Texas Tech Univ. Health Sciences Center Dept. of Medicine	El Paso	Texas	United States	79905
12	Aalborg Hospital	Aalborg		Denmark
13	Aarhus University Hospital	Aarhus		Denmark
14	Steno Diabetes Center	Gentofte		Denmark
15	Odense University Hospital	Odense		Denmark
16	Haukeland University Hospital	Bergen		Norway
17	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok		Poland
18	Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad	Lodz		Poland
19	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warsaw		Poland
20	Karolinska University Hospital	Stockholm		Sweden
21	Ipswich Hospital NHS Trust	Ipswich		United Kingdom
22	Leicester Royal Infirmary	Leicester		United Kingdom
23	Wellcome Truest Clinical Research Facility	Manchester		United Kingdom