To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00761358
First received: September 25, 2008
Last updated: November 21, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Functional Dyspepsia
Drug: Z-338
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Resource links provided by NLM:


Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • General impression at last visit in treatment period [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  • Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual symptom score [ Time Frame: Every week ] [ Designated as safety issue: No ]
  • SF-NDI [ Time Frame: At 0, 4 week and 4 week after treatment ] [ Designated as safety issue: No ]
  • General Impression [ Time Frame: Every week ] [ Designated as safety issue: No ]
  • Laboratory tests [ Time Frame: At 0, 4 week and 4 week after treatment ] [ Designated as safety issue: Yes ]
  • Adverse Event [ Time Frame: 4 week treatment period and 4 week after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 820
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Z-338 Drug: Z-338
Oral
Placebo Comparator: placebo Drug: Placebo
Oral

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761358

Locations
Japan
Hokkaido, Japan
Tokyo, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Study Director: Michio Hongo, Professor Tohoku University Hospital
  More Information

No publications provided by Zeria Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00761358     History of Changes
Other Study ID Numbers: 99010301
Study First Received: September 25, 2008
Last Updated: November 21, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Zeria Pharmaceutical:
Acotiamide

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014