YM443 in Subjects With Functional Dyspepsia

January 8, 2018 updated by: Astellas Pharma Inc

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Dose Ranging Study of YM443 in Subjects With Functional Dyspepsia

The primary objective of this study will be to characterize the dose response profile of YM443 in subjects with functional dyspepsia (FD) to enable the selection of doses for the Phase 3 clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Dr. Suresh Karne
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • James Thrasher, MD
    • California
      • Anaheim, California, United States, 92801
        • Dr. Dennis Riff
      • Cypress, California, United States, 90630
        • Dr. Peter Winkle
      • Encinitas, California, United States, 92024
        • Dr. Ramin Farsad
      • Fresno, California, United States, 93703
        • Dr. Prahalad Jajodia
      • Fresno, California, United States, 93710
        • Dr. Gurmej Dhillon
      • Orange, California, United States, 92869
        • Dr. Steven Duckor
      • Roseville, California, United States, 95661
        • Dr. Theodor Feinstat
      • San Carlos, California, United States, 94070
        • Scott Levenson, MD
      • San Diego, California, United States, 92123
        • Dr. Michael Bennett
      • San Francisco, California, United States, 94115
        • Dr. William Snape
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Dr. Abbass Shafii
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Dr. Julio Salcedo
    • Florida
      • Gainesville, Florida, United States, 32605
        • Dr. Daniel Maico
      • Hialeah, Florida, United States, 33013
        • Dr. Simon Behar
      • Hollywood, Florida, United States, 33021
        • Wayne Schonfeld, MD
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Dr. Stephen Palte
      • Atlanta, Georgia, United States, 30342
        • Dr. Nathan Segall
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Azazuddin Ahmed, MD
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Brian Covey, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Dr. Richard McCallum
      • Topeka, Kansas, United States, 66606
        • Robert Braun, MD
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Carroll Steinfeld, MD
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • David Dulitz, MD
      • Monroe, Louisiana, United States, 71201
        • Dr. Bal Raj Bhandari
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Dr. Robert Hardi
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Dr. Braden Kuo
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Dr. Robert Lustig
      • Trenton, New Jersey, United States, 08618
        • Dr. Rejendra Prasad Gupta
      • West Orange, New Jersey, United States, 07052
        • Dr. Vitaly Fishbein
    • New York
      • Brooklyn, New York, United States, 11222
        • Dr. Wieslaw Ignatowicz
      • Great Neck, New York, United States, 11021
        • Dr. Eugene Bonapace
      • Mineola, New York, United States, 11501
        • Dr. James Grendell
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Dr. William Harlan
      • Fayetteville, North Carolina, United States, 28304
        • Dr. John Poulos
      • Jacksonville, North Carolina, United States, 28546
        • Dr. Peter Eweje
      • Raleigh, North Carolina, United States, 27812
        • Dr. Charles Barish
      • Wilmington, North Carolina, United States, 28401
        • Dr. William Gramley
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Dr. Robert Kindel
      • Cleveland, Ohio, United States, 44106
        • Dr. Gregory Cooper
      • Cleveland, Ohio, United States, 44195
        • Dr. Gary Falk
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Dr. Michael Grossman
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Michael Mirhej, MD
    • Pennsylvania
      • Eynon, Pennsylvania, United States, 18403
        • Dr. Nayan Shah
      • Philadelphia, Pennsylvania, United States, 19140
        • Dr. Robert Fisher
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Dr. Cynthia Strout
      • Saluda, South Carolina, United States, 29138
        • Robert Smith, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Dr. Richard Krause
      • Jackson, Tennessee, United States, 38305
        • Dr. Mark Swaim
      • Nashville, Tennessee, United States, 37203
        • George James, MD
      • Nashville, Tennessee, United States, 37205
        • Dr. Ronald Pruitt
    • Texas
      • Dallas, Texas, United States, 75224
        • Dr. James Race
      • Houston, Texas, United States, 77090
        • Sardar Khan, MD
      • McAllen, Texas, United States, 78503
        • Ralph Alhalel, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Dr. Daniel Pambianco
      • Christiansburg, Virginia, United States, 24073
        • Dr. Mark Ringold
      • Fairfax, Virginia, United States, 22031
        • Vinod Rustgi, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Dr. Michael Schmalz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to read and write in English.
  • Written informed consent has been obtained.
  • 18-75 years of age on the day the Informed Consent Form is signed.
  • Men or women.
  • Females, not pregnant, lactating or likely to become pregnant.
  • Abdominal ultrasound and/or upper endoscopy findings that are judged as not clinically significant by the Investigator during Screening or within 4 weeks prior to Screening.
  • Symptoms of FD at Visits 1 and 4 as defined by Rome II criteria.
  • Subjects with a positive H. pylori breath test at Screening may be included in the study.
  • Subjects with pH-metry results at Screening indicative of reflux may be included in the study.
  • ECG, vital signs, and laboratory results that are judged as not clinically significant by the Investigator during Screening.

Exclusion Criteria:

  • Significant renal, hepatic, bilirubin, cardiovascular, pulmonary, endocrine, metabolic, hematological, neurologic, or gastrointestinal (other than the one being studied) condition.
  • Subjects with diabetes mellitus are to be excluded.
  • Congenital or acquired long QT syndrome, or uncontrolled arrhythmias.
  • Prior surgery on the luminal GI tract.
  • History of any major psychiatric disorder, current depression or anxiety, alcohol abuse, or substance abuse in the last 2 years.
  • Any evidence or treatment for malignancy (with the exception of basal cell carcinoma) within the last 5 years.
  • Confirmed structural gastrointestinal disease.
  • Predominant symptoms of irritable bowel syndrome (IBS) (Rome II criteria) or gastroesophageal reflux disease (GERD) assessed at Visit 1 or 4.
  • Female subjects who are pregnant, lactating, or are likely to become pregnant during the study.
  • Males and females of child-bearing potential must be abstinent or agree to use contraceptive regimens throughout the study.
  • Any history or condition which, in the opinion of the Investigator, makes the subject unsuitable for any of the procedures used during this study or would not allow for safe completion of the study.
  • Known hypersensitivity to gastroprokinetics or proton pump inhibitors.
  • Use of anti-ulcer medications, antacid/acid suppression medications, gastroprokinetics, aspirin (>325 mg daily), other NSAIDs, antibiotics, and other medications that effect the GI system within 2 weeks prior to Screening. Must be able to stay off these medications during the study, except for proton pump inhibitors (PPIs) administered during the PPI Run-in Period.
  • Required use of concomitant medications known to adversely interact with other gastroprokinetic agents or proton pump inhibitors.
  • H. pylori eradication therapy (PPIs, antibiotics, bismuth preparations) in the 2 weeks prior to the upper endoscopy.
  • Treatment for H. pylori required during the study.
  • Subject has received an investigational drug within 30 days or 10 half-lives, which ever is longer, or participated in more than 3 clinical studies within 12 months, prior to Visit 1.
  • Previous treatment with YM443.
  • Employees of the Yamanouchi Group or CROs involved in the study.
  • More than one subject per household to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma US, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Monitor, APUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 443-CL-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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