Skip to main content
OpenTrials
Completed

NCT Number: NCT00761358

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Dyspepsia

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hokkaido, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Z-338

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2008
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.