Clinical trial NCT00102310: YM443 in Subjects With Functional Dyspepsia
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Dose Ranging Study of YM443 in Subjects With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Indigestion
Nausea
Keywords: Nausea
Indigestion
Bloating
Functional Dyspepsia
Fullness after Meals
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2005-01-27
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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