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Completed

NCT Number: NCT00458328

The Effect of Z-338 in Subjects With Functional Dyspepsia

Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound

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Key information

Conditions

Functioanl Dyspepsia

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-0192, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
  • Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.

Exclusion criteria

  • Subjects that heartburn should be the most bothersome symptom
  • Subjects presenting with primary complaints relieved by stool movements (IBS)
  • Subjects with diabetes by treatment
  • Subjects that heartburn should be more than moderate

Treatment and study plan

Z-338

Drug

Primary outcomes

  1. Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 10, 2007
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.

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