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

NCT ID: NCT00764374

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-12-31

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.

Conditions

Dyspepsia; Functional Dyspepsia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

YM443

Intervention Type: DRUG

oral

Interventions

YM443

oral

Intervention Type: DRUG

Other Intervention Names

Z-338; acotiamide

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Hokkaido, , Japan

Kansai, , Japan

Kantou, , Japan

Kyushu, , Japan

Countries

Japan

References

Matsueda K, Hongo M, Ushijima S, Akiho H. A long-term study of acotiamide in patients with functional dyspepsia: results from an open-label phase III trial in Japan on efficacy, safety and pattern of administration. Digestion. 2011;84(4):261-8. doi: 10.1159/000332404. Epub 2011 Sep 21.

Reference Type: BACKGROUND

PMID: 21934307 (View on PubMed)

Other Identifiers

443-CL-501

Identifier Type: -

Identifier Source: org_study_id