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

NCT00764374 | Completed Phase 3

• 1 other identifier: 443-CL-501
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 4

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

Keywords

YM443; Z-338; Acotiamide; Rome III; Signs and symptoms, digestive

Outcome Measures

Primary Outcomes (1)

• Subject's global assessment

  Every week

Secondary Outcomes (4)

• Disappearance rate of symptoms

  Every week

• Laboratory tests, resting

  At 0, 4, 12, 24, 36, 48 week

• 12-lead ECG

  At 0, 24 and 48 week

• Adverse events

  During treatment

Study Arms (1)

1

EXPERIMENTAL

Drug: YM443

Interventions

YM443 DRUG

oral

Also known as: Z-338, acotiamide

1

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (4)

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Publications (1)

• 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.

  PMID: 21934307 BACKGROUND

MeSH Terms

Conditions

Dyspepsia; Signs and Symptoms, Digestive

Interventions

Z 338

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

JP (4)