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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00142974

Enrollment

120

Registered

2005-09-02

Start date

2004-05-31

Completion date

2005-04-30

Last updated

2012-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Gastropathy

Keywords

Diabetes, tegaserod, gastropathy

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.

Interventions

DRUGTegaserod

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026