Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

This study has been terminated.
(This study was terminated early as a result of regulatory action suspending tegaserod use in 2007)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00390975
First received: October 20, 2006
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Gastroparesis
Diabetes
Drug: Tegaserod
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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

Estimated Enrollment: 40
Study Start Date: January 2007
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390975

Locations
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
Novartis
Investigators
Study Chair: Novartis Pharmaceutical Corporation NPC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390975     History of Changes
Other Study ID Numbers: CHTF919GUS62
Study First Received: October 20, 2006
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Tegaserod
diabetes
diabetic gastroparesis
gastric emptying
gastric retention
electrogastrography

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014