Diabetic Gastroparesis
Conditions
Keywords
diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2
Brief 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.
Interventions
DRUG10 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
DRUGPlacebo
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
Sponsors
Tranzyme, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in symptoms associated with diabetic gastroparesis | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in health-related quality of life | 12 Weeks |
| Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters | 12 Weeks |
Countries
Poland, United States
Outcome results
None listed