Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroparesis; Diabetes
Intervention: Tegaserod (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceutical Corporation, Study Chair, Affiliation: NPC
Summary
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis
treated with tegaserod over 2 weeks.
Clinical Details
Official title: An Open-Label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptyingSymptoms 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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/exclusion criteria may apply.
Locations and Contacts
The University of Kansas Medical Center, Kansas City, Kansas 66160, United States
The University of Louisville, Louisville, Kentucky 40292, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Additional Information
Starting date: January 2007
Last updated: March 31, 2008
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