YM443 in Subjects With Functional Dyspepsia
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Dose Ranging Study of YM443 in Subjects With Functional Dyspepsia
1 other identifier
interventional
416
1 country
59
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2004
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2004
CompletedFirst Submitted
Initial submission to the registry
January 26, 2005
CompletedFirst Posted
Study publicly available on registry
January 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2006
CompletedJanuary 10, 2018
June 1, 2015
2 years
January 26, 2005
January 8, 2018
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Ability to read and write in English.
- Written informed consent has been obtained.
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (59)
Dr. Suresh Karne
Huntsville, Alabama, 35802, United States
James Thrasher, MD
Little Rock, Arkansas, 72205, United States
Dr. Dennis Riff
Anaheim, California, 92801, United States
Dr. Peter Winkle
Cypress, California, 90630, United States
Dr. Ramin Farsad
Encinitas, California, 92024, United States
Dr. Prahalad Jajodia
Fresno, California, 93703, United States
Dr. Gurmej Dhillon
Fresno, California, 93710, United States
Dr. Steven Duckor
Orange, California, 92869, United States
Dr. Theodor Feinstat
Roseville, California, 95661, United States
Scott Levenson, MD
San Carlos, California, 94070, United States
Dr. Michael Bennett
San Diego, California, 92123, United States
Dr. William Snape
San Francisco, California, 94115, United States
Dr. Abbass Shafii
Colorado Springs, Colorado, 80909, United States
Dr. Julio Salcedo
Washington D.C., District of Columbia, 20010, United States
Dr. Daniel Maico
Gainesville, Florida, 32605, United States
Dr. Simon Behar
Hialeah, Florida, 33013, United States
Wayne Schonfeld, MD
Hollywood, Florida, 33021, United States
Dr. Stephen Palte
Atlanta, Georgia, 30339, United States
Dr. Nathan Segall
Atlanta, Georgia, 30342, United States
Azazuddin Ahmed, MD
Oak Brook, Illinois, 60523, United States
Brian Covey, MD
Dubuque, Iowa, 52001, United States
Dr. Richard McCallum
Kansas City, Kansas, 66160, United States
Robert Braun, MD
Topeka, Kansas, 66606, United States
Carroll Steinfeld, MD
Madisonville, Kentucky, 42431, United States
David Dulitz, MD
Metairie, Louisiana, 70006, United States
Dr. Bal Raj Bhandari
Monroe, Louisiana, 71201, United States
Dr. Robert Hardi
Chevy Chase, Maryland, 20815, United States
Dr. Braden Kuo
Boston, Massachusetts, 02114, United States
Dr. Robert Lustig
Bridgewater, New Jersey, 08807, United States
Dr. Rejendra Prasad Gupta
Trenton, New Jersey, 08618, United States
Dr. Vitaly Fishbein
West Orange, New Jersey, 07052, United States
Dr. Wieslaw Ignatowicz
Brooklyn, New York, 11222, United States
Dr. Eugene Bonapace
Great Neck, New York, 11021, United States
Dr. James Grendell
Mineola, New York, 11501, United States
Dr. William Harlan
Asheville, North Carolina, 28801, United States
Dr. John Poulos
Fayetteville, North Carolina, 28304, United States
Dr. Peter Eweje
Jacksonville, North Carolina, 28546, United States
Dr. Charles Barish
Raleigh, North Carolina, 27812, United States
Dr. William Gramley
Wilmington, North Carolina, 28401, United States
Dr. Robert Kindel
Cincinnati, Ohio, 45220, United States
Dr. Gregory Cooper
Cleveland, Ohio, 44106, United States
Dr. Gary Falk
Cleveland, Ohio, 44195, United States
Dr. Michael Grossman
Oklahoma City, Oklahoma, 73112, United States
Michael Mirhej, MD
Eugene, Oregon, 97401, United States
Dr. Nayan Shah
Eynon, Pennsylvania, 18403, United States
Dr. Robert Fisher
Philadelphia, Pennsylvania, 19140, United States
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, 29464, United States
Robert Smith, MD
Saluda, South Carolina, 29138, United States
Dr. Richard Krause
Chattanooga, Tennessee, 37404, United States
Dr. Mark Swaim
Jackson, Tennessee, 38305, United States
George James, MD
Nashville, Tennessee, 37203, United States
Dr. Ronald Pruitt
Nashville, Tennessee, 37205, United States
Dr. James Race
Dallas, Texas, 75224, United States
Sardar Khan, MD
Houston, Texas, 77090, United States
Ralph Alhalel, MD
McAllen, Texas, 78503, United States
Dr. Daniel Pambianco
Charlottesville, Virginia, 22911, United States
Dr. Mark Ringold
Christiansburg, Virginia, 24073, United States
Vinod Rustgi, MD
Fairfax, Virginia, 22031, United States
Dr. Michael Schmalz
Milwaukee, Wisconsin, 53215, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
APUS
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2005
First Posted
January 27, 2005
Study Start
March 10, 2004
Primary Completion
March 11, 2006
Study Completion
March 11, 2006
Last Updated
January 10, 2018
Record last verified: 2015-06