Back to resultsTo Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Z-338
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Acotiamide
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Z-338
placebo
Arm Description
Outcomes
Primary Outcome Measures
General impression at last visit in treatment period
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
Secondary Outcome Measures
Individual symptom score
SF-NDI
General Impression
Laboratory tests
Adverse Event
Full Information
NCT ID
NCT00761358
First Posted
September 25, 2008
Last Updated
November 21, 2010
Sponsor
Zeria Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00761358
Brief Title
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Official Title
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Acotiamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
820 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Z-338
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Z-338
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
General impression at last visit in treatment period
Time Frame
4 week
Title
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Individual symptom score
Time Frame
Every week
Title
SF-NDI
Time Frame
At 0, 4 week and 4 week after treatment
Title
General Impression
Time Frame
Every week
Title
Laboratory tests
Time Frame
At 0, 4 week and 4 week after treatment
Title
Adverse Event
Time Frame
4 week treatment period and 4 week after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michio Hongo, Professor
Organizational Affiliation
Tohoku University Hospital
Official's Role
Study Director
Facility Information:
City
Hokkaido
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22157329
Citation
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.
Results Reference
derived
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To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
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