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

• Sponsor: Novartis (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00142974
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Gastropathy	Drug: Tegaserod	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Weekly global measure of dyspeptic symptom relief. []

2. Weekly mean severity of individual dyspeptic symptoms (nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety). []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis	Basel		Switzerland	4056

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00142974
• Other Study ID Numbers: CHTF919G2203
• First Posted: Sep 2, 2005
• Last Update Posted: Apr 20, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Novartis: Diabetes, tegaserod, gastropathy
• Additional relevant MeSH terms: Stomach Diseases; Tegaserod

Study Results

No Results Posted as of Apr 20, 2012