A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Phase 3

Completed

• Conditions: Functional Dyspepsia; Dyspepsia
• Interventions: Drug: YM443

• Registration Number: NCT00764374
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent

  • postprandial fullness
  • early satiation
  • upper abdominal pain
  • upper abdominal discomfort

• Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.)

• Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent

  • upper abdominal pain
  • upper abdominal discomfort
  • postprandial fullness
  • bloating in the upper abdomen
  • early satiation
  • nausea
  • vomiting
  • belching

• Outpatient

Exclusion Criteria

• Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent
• Patient showing heartburn within 12 weeks before obtaining consent
• Patient complicated by irritable bowel syndrome
• Patient complicated by diabetes mellitus requiring medication
• Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life
• Patient complicated by depression (including suspected cases) or sleep disturbance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	YM443	-

Primary Outcome Measures

Name	Time	Method
Subject's global assessment	Every week

Secondary Outcome Measures

Name	Time	Method
12-lead ECG	At 0, 24 and 48 week
Adverse events	During treatment
Disappearance rate of symptoms	Every week
Laboratory tests, resting	At 0, 4, 12, 24, 36, 48 week