Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
Phase 2
Terminated
- Conditions
- Diabetic Gastropathy
- Registration Number
- NCT00142974
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland