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 2TerminatedNCT00142974

Novartis120 enrolled

Overview

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

120

Conditions

Diabetic Gastropathy

Interventions

TegaserodDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.