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”

This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

• 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 Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceutical Corporation Study Chair NPC  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00390975

Study ID Number: CHTF919GUS62

ClinicalTrials.gov Identifier: NCT00390975

Health Authority: United States: Food and Drug Administration