YM443 in Subjects With Functional Dyspepsia

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102310
• Other study ID #: 443-CL-008
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2005
• Last updated: January 8, 2018
• Start date: March 10, 2004
• Est. completion date: March 11, 2006

Study information

• Verified date: June 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: March 11, 2006
• Est. primary completion date: March 11, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Indigestion
• Nausea

Intervention

Drug:
• YM443

Locations

Country	Name	City	State
United States	Dr. Dennis Riff	Anaheim	California
United States	Dr. William Harlan	Asheville	North Carolina
United States	Dr. Nathan Segall	Atlanta	Georgia
United States	Dr. Stephen Palte	Atlanta	Georgia
United States	Dr. Braden Kuo	Boston	Massachusetts
United States	Dr. Robert Lustig	Bridgewater	New Jersey
United States	Dr. Wieslaw Ignatowicz	Brooklyn	New York
United States	Dr. Daniel Pambianco	Charlottesville	Virginia
United States	Dr. Richard Krause	Chattanooga	Tennessee
United States	Dr. Robert Hardi	Chevy Chase	Maryland
United States	Dr. Mark Ringold	Christiansburg	Virginia
United States	Dr. Robert Kindel	Cincinnati	Ohio
United States	Dr. Gary Falk	Cleveland	Ohio
United States	Dr. Gregory Cooper	Cleveland	Ohio
United States	Dr. Abbass Shafii	Colorado Springs	Colorado
United States	Dr. Peter Winkle	Cypress	California
United States	Dr. James Race	Dallas	Texas
United States	Brian Covey, MD	Dubuque	Iowa
United States	Dr. Ramin Farsad	Encinitas	California
United States	Michael Mirhej, MD	Eugene	Oregon
United States	Dr. Nayan Shah	Eynon	Pennsylvania
United States	Vinod Rustgi, MD	Fairfax	Virginia
United States	Dr. John Poulos	Fayetteville	North Carolina
United States	Dr. Gurmej Dhillon	Fresno	California
United States	Dr. Prahalad Jajodia	Fresno	California
United States	Dr. Daniel Maico	Gainesville	Florida
United States	Dr. Eugene Bonapace	Great Neck	New York
United States	Dr. Simon Behar	Hialeah	Florida
United States	Wayne Schonfeld, MD	Hollywood	Florida
United States	Sardar Khan, MD	Houston	Texas
United States	Dr. Suresh Karne	Huntsville	Alabama
United States	Dr. Mark Swaim	Jackson	Tennessee
United States	Dr. Peter Eweje	Jacksonville	North Carolina
United States	Dr. Richard McCallum	Kansas City	Kansas
United States	James Thrasher, MD	Little Rock	Arkansas
United States	Carroll Steinfeld, MD	Madisonville	Kentucky
United States	Ralph Alhalel, MD	McAllen	Texas
United States	David Dulitz, MD	Metairie	Louisiana
United States	Dr. Michael Schmalz	Milwaukee	Wisconsin
United States	Dr. James Grendell	Mineola	New York
United States	Dr. Bal Raj Bhandari	Monroe	Louisiana
United States	Dr. Cynthia Strout	Mount Pleasant	South Carolina
United States	Dr. Ronald Pruitt	Nashville	Tennessee
United States	George James, MD	Nashville	Tennessee
United States	Azazuddin Ahmed, MD	Oak Brook	Illinois
United States	Dr. Michael Grossman	Oklahoma City	Oklahoma
United States	Dr. Steven Duckor	Orange	California
United States	Dr. Robert Fisher	Philadelphia	Pennsylvania
United States	Dr. Charles Barish	Raleigh	North Carolina
United States	Dr. Theodor Feinstat	Roseville	California
United States	Robert Smith, MD	Saluda	South Carolina
United States	Scott Levenson, MD	San Carlos	California
United States	Dr. Michael Bennett	San Diego	California
United States	Dr. William Snape	San Francisco	California
United States	Robert Braun, MD	Topeka	Kansas
United States	Dr. Rejendra Prasad Gupta	Trenton	New Jersey
United States	Dr. Julio Salcedo	Washington	District of Columbia
United States	Dr. Vitaly Fishbein	West Orange	New Jersey
United States	Dr. William Gramley	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   Link to results on Astellas Clinical Study Results website