ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00761358
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Zeria Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Z-338 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Z-338 Drug: Z-338
Oral
Placebo Comparator: placebo Drug: Placebo
Oral



Primary Outcome Measures :
  1. General impression at last visit in treatment period [ Time Frame: 4 week ]
  2. Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period [ Time Frame: 4 week ]

Secondary Outcome Measures :
  1. Individual symptom score [ Time Frame: Every week ]
  2. SF-NDI [ Time Frame: At 0, 4 week and 4 week after treatment ]
  3. General Impression [ Time Frame: Every week ]
  4. Laboratory tests [ Time Frame: At 0, 4 week and 4 week after treatment ]
  5. Adverse Event [ Time Frame: 4 week treatment period and 4 week after treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761358


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00761358     History of Changes
Other Study ID Numbers: 99010301
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

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