Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

NCT ID: NCT00390975

Last Updated: 2012-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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Conditions

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Gastroparesis Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceutical Corporation

Role: STUDY_CHAIR

NPC

Locations

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The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

The University of Louisville

Louisville, Kentucky, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CHTF919GUS62

Identifier Type: -

Identifier Source: org_study_id

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