A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of Once-Daily Administrations of TZP-102 for the Treatment of Symptoms Associated With Diabetic Gastroparesis
Overview
- Phase
- Phase 2
- Intervention
- 20mg TZP-102
- Conditions
- Gastroparesis
- Sponsor
- Tranzyme, Inc.
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Change from baseline in symptoms associated with diabetic gastroparesis
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
3
20mg TZP-102
Intervention: 20mg TZP-102
1
Drug: placebo
Intervention: Placebo
2
10mg TZP-102
Intervention: 10mg TZP-102
Outcomes
Primary Outcomes
Change from baseline in symptoms associated with diabetic gastroparesis
Time Frame: 12 Weeks
Secondary Outcomes
- Change from baseline on health-related quality of life(12 Weeks)
- Adverse Events (AEs)(12 Weeks)
- Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG)(12 Weeks)
- Clinical Chemistry and Hematology Parameters(12 Weeks)