Diabetes, Gastroparesis
Conditions
Keywords
Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
Brief summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Females and males 18 to 75 years of age * History of type I or type II diabetes mellitus for more than 3 years * History of upper gastrointestinal symptoms consistent with diabetic gastroparesis * Hemoglobin A1c \< 9.5% * Delayed gastric emptying
Exclusion criteria
* Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms * Medical conditions affecting gastric emptying * A clinically significant medical condition that would interfere with the patient completing the trial * Clinically significant abnormal creatinine level * Known allergies to the same class of drug and/or allergies to eggs * Severe obesity Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying | — |
| Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort | — |
| Volume and symptomatic response to a gastric satiety drink test (GSDT) | — |
| Electrogastrography (EGG) | — |
| The safety and tolerability of tegaserod | — |
Countries
United States
Outcome results
None listed