Clinical trial NCT00764374: A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Official title: A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Functional Dyspepsia
Keywords: YM443
Z-338
Acotiamide
Rome III
Signs and symptoms, digestive
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 412
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subject's global assessment
timeFrame: Every week
Secondary outcomes:
measure: Disappearance rate of symptoms
timeFrame: Every week
measure: Laboratory tests, resting
timeFrame: At 0, 4, 12, 24, 36, 48 week
measure: 12-lead ECG
timeFrame: At 0, 24 and 48 week
measure: Adverse events
timeFrame: During treatment
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
citation: 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.