AzTrials
AzTrials

IndigestionPhase 2NCT00102310

YM443 in Subjects With Functional Dyspepsia

A Phase 2 study testing YM443 in people with Indigestion and Nausea, run by Astellas Pharma Inc at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Indigestion, Nausea
What is being tested?
YM443
How many people
416 participants
Where
59 sitesUnited States
Study dates
10 Mar 2004to 11 Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Dr. Dennis Riff

    Anaheim, California, 92801

  • Dr. William Harlan

    Asheville, North Carolina, 28801

  • Dr. Stephen Palte

    Atlanta, Georgia, 30339

  • Dr. Nathan Segall

    Atlanta, Georgia, 30342

  • Dr. Braden Kuo

    Boston, Massachusetts, 02114

  • Dr. Robert Lustig

    Bridgewater, New Jersey, 08807

  • Dr. Wieslaw Ignatowicz

    Brooklyn, New York, 11222

  • Dr. Daniel Pambianco

    Charlottesville, Virginia, 22911

  • Dr. Richard Krause

    Chattanooga, Tennessee, 37404

  • Dr. Robert Hardi

    Chevy Chase, Maryland, 20815

  • Dr. Mark Ringold

    Christiansburg, Virginia, 24073

  • Dr. Robert Kindel

    Cincinnati, Ohio, 45220

  • Dr. Gregory Cooper

    Cleveland, Ohio, 44106

  • Dr. Gary Falk

    Cleveland, Ohio, 44195

  • Dr. Abbass Shafii

    Colorado Springs, Colorado, 80909

  • Dr. Peter Winkle

    Cypress, California, 90630

  • Dr. James Race

    Dallas, Texas, 75224

  • Brian Covey, MD

    Dubuque, Iowa, 52001

  • Dr. Ramin Farsad

    Encinitas, California, 92024

  • Michael Mirhej, MD

    Eugene, Oregon, 97401

  • Dr. Nayan Shah

    Eynon, Pennsylvania, 18403

  • Vinod Rustgi, MD

    Fairfax, Virginia, 22031

  • Dr. John Poulos

    Fayetteville, North Carolina, 28304

  • Dr. Prahalad Jajodia

    Fresno, California, 93703

  • Dr. Gurmej Dhillon

    Fresno, California, 93710

  • Dr. Daniel Maico

    Gainesville, Florida, 32605

  • Dr. Eugene Bonapace

    Great Neck, New York, 11021

  • Dr. Simon Behar

    Hialeah, Florida, 33013

  • Wayne Schonfeld, MD

    Hollywood, Florida, 33021

  • Sardar Khan, MD

    Houston, Texas, 77090

  • Dr. Suresh Karne

    Huntsville, Alabama, 35802

  • Dr. Mark Swaim

    Jackson, Tennessee, 38305

  • Dr. Peter Eweje

    Jacksonville, North Carolina, 28546

  • Dr. Richard McCallum

    Kansas City, Kansas, 66160

  • James Thrasher, MD

    Little Rock, Arkansas, 72205

  • Carroll Steinfeld, MD

    Madisonville, Kentucky, 42431

  • Ralph Alhalel, MD

    McAllen, Texas, 78503

  • David Dulitz, MD

    Metairie, Louisiana, 70006

  • Dr. Michael Schmalz

    Milwaukee, Wisconsin, 53215

  • Dr. James Grendell

    Mineola, New York, 11501

  • Dr. Bal Raj Bhandari

    Monroe, Louisiana, 71201

  • Dr. Cynthia Strout

    Mt. Pleasant, South Carolina, 29464

  • George James, MD

    Nashville, Tennessee, 37203

  • Dr. Ronald Pruitt

    Nashville, Tennessee, 37205

  • Azazuddin Ahmed, MD

    Oak Brook, Illinois, 60523

  • Dr. Michael Grossman

    Oklahoma City, Oklahoma, 73112

  • Dr. Steven Duckor

    Orange, California, 92869

  • Dr. Robert Fisher

    Philadelphia, Pennsylvania, 19140

  • Dr. Charles Barish

    Raleigh, North Carolina, 27812

  • Dr. Theodor Feinstat

    Roseville, California, 95661

  • Robert Smith, MD

    Saluda, South Carolina, 29138

  • Scott Levenson, MD

    San Carlos, California, 94070

  • Dr. Michael Bennett

    San Diego, California, 92123

  • Dr. William Snape

    San Francisco, California, 94115

  • Robert Braun, MD

    Topeka, Kansas, 66606

  • Dr. Rejendra Prasad Gupta

    Trenton, New Jersey, 08618

  • Dr. Julio Salcedo

    Washington D.C., District of Columbia, 20010

  • Dr. Vitaly Fishbein

    West Orange, New Jersey, 07052

  • Dr. William Gramley

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: 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.

Conditions
Indigestion, Nausea
Being tested
YM443
Keywords
Nausea, Indigestion, Bloating, Functional Dyspepsia, Fullness after Meals
Medical subject headings
Dyspepsia, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YM443Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2005 (estimated)
  2. Study start10 Mar 2004
  3. Primary completion11 Mar 2006
  4. Study completion11 Mar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102310
Sponsor's protocol ID
443-CL-008
Status last verified
Jun 2015
First submitted
26 Jan 2005
Last updated
10 Jan 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YM443 in people with Indigestion and Nausea, run by Astellas Pharma Inc at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00102310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in