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Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

This study has been terminated.
(This study was terminated early in April 2005 due to low patient enrollment)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00142974
First received: August 31, 2005
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

This study is being done to evaluate the safety, tolerability and satisfactory relief of tegaserod against dyspeptic symptoms in diabetic patients with symptoms of diabetic gastropathy.


Condition Intervention Phase
Diabetic Gastropathy
 Drug: Tegaserod
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.

Secondary Outcome Measures:
  • Weekly global measure of dyspeptic symptom relief.
  • Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).

Estimated Enrollment: 120
Study Start Date: May 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • History of Type 1 or insulin-requiring Type 2 diabetes for at least 3 years
  • GI symptoms for at least 2 months before entering study

Exclusion Criteria:

  • Very high body weight
  • Significant diarrhea
  • Ulcers

Symptom severity score collected via diary Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142974

Locations
Switzerland
Novartis
Basel, Switzerland, 4056
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Basel
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00142974     History of Changes
Other Study ID Numbers: CHTF919G2203
Study First Received: August 31, 2005
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Diabetes, tegaserod, gastropathy

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
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 May 21, 2013