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

Diabetic Gastropathy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00142974
• Other study ID #: CHTF919G2203
• Status: Terminated
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: April 19, 2012
• Start date: May 2004
• Est. completion date: April 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Diabetic Gastropathy
• Stomach Diseases

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in weekly mean of a daily composite diabetic gastropathy dyspeptic symptom severity score throughout 6 weeks of treatment.
Secondary	Weekly global measure of dyspeptic symptom relief.
Secondary	Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety).