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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452815
Other study ID # TZP-102-CL-G003
Secondary ID
Status Completed
Phase Phase 2
First received October 12, 2011
Last updated April 24, 2013
Start date September 2011
Est. completion date November 2012

Study information

Verified date August 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 ProductsBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Paul-Ehrlich-InstitutNorway: Norwegian Medicines AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.


Description:

Considered subjects will be screened to determine eligibility for entry into the study. The Screening Visit must take place at least 14 days, but not more than 21 days, before the planned date of study entry (randomization and administration of the first dose of study drug on Study Day 1). The baseline evaluation of gastric emptying must be scheduled at least 7 days (in the U.S.) and 10 days (in Europe) before the Day 1 Visit. Subjects will answer questions relating to their gastroparesis symptoms in an electronic diary (like a palm pilot) beginning on the first day of the screening period.

Eligible subjects will be randomized to receive placebo or one of two dosages of TZP-102 (10mg or 20mg) once daily for 12 weeks. After randomization and administration of the first dose of study drug on Study Day 1 (the Study Entry Visit), subsequent visits to the clinic will be scheduled every two weeks during the 12-week Treatment period and 4-week Follow-Up Period.

All visits will be conducted on an outpatient basis. Visits for a given subject throughout the study should be scheduled to start at approximately the same time, in the morning. Subjects will be instructed to take their daily dose of study drug each morning (when not attending a study visit), at least 30 minutes before breakfast. Subjects will be instructed to not take study drug on the morning of each treatment period visit and to bring study drug supplies with them to the clinic; study drug will be administered in the clinic after all scheduled assessments/procedures (after all pre-dose assessments at each of the Day 1 and Week 12 Visits) are completed.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date November 2012
Est. primary completion date November 2012
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

- Gastric half-emptying time >82 minutes, demonstrated by the Gastric Emptying Breath Test performed at the Screening Visit OR documented delayed gastric emptying within the previous 24 months

- Mild to moderate severity of gastroparesis symptoms during the screening period

- Body Mass Index (BMI) < 45.0 at the Screening Visit

- Glycosylated hemoglobin (HbA1c) level < 11.0% at the Screening 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 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:

- Persistent daily vomiting

- 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 within 2 weeks prior to the Screening Visit

- Required in-patient hospitalization for treatment of 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

- Participated in an investigational study within 30 days prior to the Screening Visit

- Chronic severe diarrhea

- Diabetic ketoacidosis that required inpatient hospitalization within 30 days prior to the Screening Visit

- History of any eating disorder within 2 years prior to the Screening Visit

- Chronic obstructive pulmonary disease (COPD) or chronic asthma

- Chronic smoker that is unable or unwilling to abstain from smoking during the two visits that the gastric emptying breath test will be performed

- History of risk factors for Torsades de Pointes

- Corrected QT interval calculated using Fredericia's formula >= 500 msec, recorded and confirmed on any of the three ECG assessments performed during the screening period

- Bradycardia or hypotension assessed as clinically-significant by the investigator

- Requires treatment with concomitant medication that is a substrate of Cytochrome P450 isoenzyme 3A4 and known to have a clinically recognized risk for Torsades de Pointes

- History of acute myocardial infarction, unstable angina or a transient (cerebral) ischemic attack within 12 months prior to the Screening Visit

- History of severe depression, psychiatric disorder or cognitive impairment

- History of alcohol or drug abuse or dependency within 2 years prior to the Screening Visit

- Taking opiates for abdominal pain

- Known history of Hepatitis B or C or HIV infection

- Requires dialysis or elevated creatinine at the Screening Visit

- Abnormal liver function tests at the Screening Visit

- Uncontrolled hypo- or hyperthyroidism

- Adrenal insufficiency

- Active malignancy other than basal cell or squamous cell carcinoma of the skin

- Pregnant or breast-feeding

- Allergies to components of the breath test meal or severe lactose intolerance

- 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, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Placebo
Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.
10mg TZP-102
One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks
20mg TZP-102
Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients

Locations

Country Name City State
Belgium Tranzyme Investigational Site Brugge
Belgium Tranzyme Investigational Site Bruxelles
Belgium Tranzyme Investigational Site Gent
Denmark Tranzyme Investigational Site Aarhus
Denmark Tranzyme Investigational Site Gentofte
Denmark Tranzyme Investigational Site Odense
Finland Tranzyme Investigational Site Porvoo
Finland Tranzyme Investigational Site Tampere
Germany Tranzyme Investigational Site Essen
Germany Tranzyme Investigational Site Mainz
Germany Tranzyme Investigational Site Stuttgart
Norway Tranzyme Investigational Site Bergen
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 Olsztyn
Poland Tranzyme Investigational Site Warszawa
Sweden Tranzyme Investigational Site Stockholm
Sweden Tranzyme Investigational Site Uppsala
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 Fayetteville North Carolina
United States Tranzyme Investigational Site Hialeah Florida
United States Tranzyme Investigational Site Houston Texas
United States Tranzyme Investigational Site Huntsville Alabama
United States Tranzyme Investigational Site Inverness Florida
United States Tranzyme Investigational Site Jackson Tennessee
United States Tranzyme Investigational Site Jacksonville Florida
United States Tranzyme Investigational Site Jonesboro Arkansas
United States Tranzyme Investigational Site Kansas City Kansas
United States Tranzyme Investigational Site Little Rock Arkansas
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 Oak Lawn Illinois
United States Tranzyme Investigational Site Oklahoma City Oklahoma
United States Tranzyme Investigational Site Philadelphia Pennsylvania
United States Tranzyme Investigational Site Port Orange Florida
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 Stanford California
United States Tranzyme Investigational Site Tacoma Washington
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,  Belgium,  Denmark,  Finland,  Germany,  Norway,  Poland,  Sweden, 

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 on health-related quality of life 12 Weeks No
Secondary Adverse Events (AEs) 12 Weeks Yes
Secondary Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG) 12 Weeks Yes
Secondary Clinical Chemistry and Hematology Parameters 12 Weeks Yes
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