To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
1 other identifier
interventional
820
1 country
2
Brief Summary
The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 23, 2010
November 1, 2010
1.7 years
September 25, 2008
November 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
General impression at last visit in treatment period
4 week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
4 week
Secondary Outcomes (5)
Individual symptom score
Every week
SF-NDI
At 0, 4 week and 4 week after treatment
General Impression
Every week
Laboratory tests
At 0, 4 week and 4 week after treatment
Adverse Event
4 week treatment period and 4 week after treatment
Study Arms (2)
Z-338
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
- Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
- Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent
You may not qualify if:
- Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
- Subjects have heartburn in last 12 weeks before obtaining informed consent
- Subjects with irritable bowel disease (IBS)
- Subjects with diabetes mellitus requiring treatment
- Subjects with serious anxiety disorder
- Subjects with depression and/or sleep disorder
- Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Hokkaido, Japan
Unknown Facility
Tokyo, Japan
Related Publications (1)
Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9.
PMID: 22157329DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Michio Hongo, Professor
Tohoku University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 29, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2010
Study Completion
August 1, 2010
Last Updated
November 23, 2010
Record last verified: 2010-11