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

6-WEEK MULTICENTER STUDY, RANDOMIZED, A DOUBLE-BLIND, PLACEBO-CONTROLLED AND SIMILARLY APPEARED MEDICATIONS, TO EVALUATE THE EFFECT OF TEGASEROD ADMINISTERED AT DOSES OF 2 MG THREE TIMES PER DAY AND 6MG DISPPSY IN DIABETIC PATIENTS WITH SYMPTOMS OF DIABETIC GASTROPATHY.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-007-04
Enrollment
3
Registered
2004-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

tegaserod 2 mg Type of group
tegaserod administered in a dose of 2 mg three times a day Group name:placebo Type of group
Tegaserod placebo will be administered three times per day

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Outcome name:dyspeptic symptoms of composite diabetic gastropathy. Measure:Reduction in the weekly average of a daily score of severity of dyspeptic symptoms of diabetic gastropathy composed over 6 weeks of treatment. Timepoints:weekly—

Secondary

MeasureTime frame
Outcome name:nausea, vomiting, retching, epigastric/stomach, discomfort/pain, postprandial fullness, bloating, early satiety. Measure:Weekly mean severity of individual dyspeptic symptoms Timepoints:weekly—

Countries

Peru, Switzerland

Outcome results

None listed

Source: REPEC (via WHO ICTRP)