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”

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.

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod

Primary Measures

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

Secondary 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).

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Basel  

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142974

Study ID Number: CHTF919G2203

ClinicalTrials.gov Identifier: NCT00142974

Health Authority: United States: Food and Drug Administration