Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 20, 2006

Last Updated Date

March 31, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

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).

Change History

Complete list of historical versions of study NCT00390975 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Gastroparesis
Diabetes

Intervention ^ICMJE

Drug: Tegaserod

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00390975

Responsible Party

Study ID Numbers ^ICMJE

CHTF919GUS62

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceutical Corporation

NPC

Information Provided By

Novartis

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP