Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic Gastropathy
Not Applicable
- Conditions
- Insulin-dependent diabetes mellitus, with neurological complications-E104 Insulin-dependent diabetes mellitus, with neurological complicationsE104
- Registration Number
- PER-007-04
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Men and women between 18 to 65 years of age.
2. With a history of diabetes mellitus type 1 and type 2 with insulin requirement for at least 3 years; and a history of dyspeptic symptoms due to diabetic gastropathy.
3. Those who agree to maintain their diet and exercise level prior to the study throughout the course of it.
Exclusion Criteria
1. Those with an abnormal high gastrointestinal endoscopy performed during the 6 months prior to selection.
2. With conditions that are known to affect gastric emptying.
3. With erosive esophagitis, gastric ulcer or duodenal ulcer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:dyspeptic symptoms of composite diabetic gastropathy.<br>Measure:Reduction in the weekly average of a daily score of severity of dyspeptic symptoms of diabetic gastropathy composed over 6 weeks of treatment.<br>Timepoints:weekly<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety.<br><br>Measure:Weekly mean severity of individual dyspeptic symptoms<br>Timepoints:weekly<br>