Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00390975
• Other study ID #: CHTF919GUS62
• Status: Terminated
• Phase: Phase 4
• First received: October 20, 2006
• Last updated: May 3, 2012
• Start date: January 2007
• Est. completion date: March 2007

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Gastroparesis

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	The University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
Secondary	Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
Secondary	Volume and symptomatic response to a gastric satiety drink test (GSDT)
Secondary	Electrogastrography (EGG)
Secondary	The safety and tolerability of tegaserod