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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764374
• Other study ID #: 443-CL-501
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: October 28, 2014
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• YM443
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's global assessment		Every week	No
Secondary	Disappearance rate of symptoms		Every week	No
Secondary	Laboratory tests, resting		At 0, 4, 12, 24, 36, 48 week	Yes
Secondary	12-lead ECG		At 0, 24 and 48 week	Yes
Secondary	Adverse events		During treatment	Yes

External Links

•   Link to Results on JAPIC - enter 140642 in the JapicCTI-RNo. field (Japanese record)