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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • 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

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

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Investigators

  • 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)

March 10, 2004

Primary Completion (Actual)

March 11, 2006

Study Completion (Actual)

March 11, 2006

Study Registration Dates

First Submitted

January 26, 2005

First Submitted That Met QC Criteria

January 26, 2005

First Posted (Estimate)

January 27, 2005

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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