Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050609

Enrollment

Registered

2002-12-18

Start date

2003-02-28

Completion date

2003-09-30

Last updated

2007-11-20

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

Conditions

Gastroparesis

Brief summary

The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.

Interventions

DRUGtadalafil

5 mg tadalafil tablet taken by mouth once a day for 8 weeks

DRUGplacebo

Placebo tablet taken by mouth once a day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of diabetes mellitus * Delayed gastric emptying * 3 month minimum history of chronic upper abdominal discomfort * Symptoms of dyspepsia (upset stomach)

Exclusion criteria

* Major gastrointestinal surgery or medical conditions known to affect gastric motility * Irritable Bowl Syndrome * Medications known to affect gastric motility * Angina treated with nitrates * Uncontrolled diabetes mellitus and history of certain heart problems

Design outcomes

Primary

Measure	Time frame
Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo	8 weeks

Secondary

Measure	Time frame
Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo	8 weeks
Measure of change from baseline to endpoint using the Visual Analog Score and Nepean Dyspepsia Index Symptom Checklist in patients taking 5 mg tadalafil, 20 mg tadalafil and placebo	8 weeks

Countries

Canada

Outcome results

None listed

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