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Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390975
Recruitment Status : Terminated (This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
First Posted : October 23, 2006
Last Update Posted : May 4, 2012
Information provided by:

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

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Drug: Tegaserod Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying
  2. Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort
  3. Volume and symptomatic response to a gastric satiety drink test (GSDT)
  4. Electrogastrography (EGG)
  5. The safety and tolerability of tegaserod

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390975

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United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
The University of Louisville
Louisville, Kentucky, United States, 40292
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
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Study Chair: Novartis Pharmaceutical Corporation NPC
Layout table for additonal information Identifier: NCT00390975    
Other Study ID Numbers: CHTF919GUS62
First Posted: October 23, 2006    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Novartis:
diabetic gastroparesis
gastric emptying
gastric retention
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs