The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	12/14/2016
Start Date:	December 2014
End Date:	June 2017
Contact:	Caroline Cooper
Email:	CCooper@theravance.com
Phone:	650-808-6000

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis

Study 0099 (www.gastroparesisstudy.com) explores the efficacy and safety of multiple doses
of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic
gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for
approximately 12 weeks of therapy. In addition, the study will be used to evaluate the
psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported
outcome (PRO) measure.

Inclusion Criteria:

- Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper
abdominal pain, retching or vomiting) for at least 3 months prior to Screening

- Composite score ≥2and <5 on nausea, bloating, feeling excessively full after meals,
and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening

- Delayed gastric emptying by either GES (gastric emptying scintigraphy) or
GEBT(gastric emptying breath test)

- Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg,
computed tomography) after the onset of gastroparesis symptoms

- Willing to abstain from prohibited medications, including but not limited to,
anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg,
metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to
gastric emptying test during Screening, if applicable; 24 hours prior to start of the
Baseline period; and during the Baseline Period

- GCSI-24H 7-day mean composite score ≥2.5 and <5 at Day 1

Exclusion Criteria:

- If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >11%

- Prior history of gastric surgery, including but not limited to gastrectomy, gastric
bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has
manipulated the natural anatomy of the stomach

- History of intrapyloric botulinum toxin injection within 3 months of Screening or
currently has functioning implantable electric stimulator

- History of alcohol or drug abuse or dependence within the last year prior to
Screening

We found this trial at

sites

Clinical Research Institute of Michigan,

Chesterfield, Michigan 48098

Principal Investigator: Ronald Fogel, MD

from

Chesterfield, MI

Accord Clinical Research

3635 S. Clyde Morris Blvd
Port Orange, Florida 32129

386-760-3862

Principal Investigator: Donato R. Ricci, MD

About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...

from

Port Orange, FL

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123

Principal Investigator: Jennifer Christie, MD

Phone: 404-778-0401

Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...

from

Atlanta, GA

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200

Principal Investigator: Braden Kuo, MD

Phone: 617-726-0196

from

Boston, MA

Beth Israel Deaconess Medical Center

330 Brookline Ave
Boston, Massachusetts 02215

617-667-7000

Principal Investigator: Anthony Lembo, MD

Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...

from

Boston, MA

Gastroenterology Associates of Tidewater

112 Gainsborough Square
Chesapeake, Virginia 23320

757-547-0798

Principal Investigator: Felix Tiongco, MD

from

Chesapeake, VA

Texas Clinical Research Institute

Arlington, Texas 76012

Principal Investigator: M. Tarek Al-Assi, MD

from

Arlington, TX

Summit Clinical Research, LLC

Athens, Georgia 30607

Principal Investigator: Jeffrey Williams, MD

from

Athens, GA

Atlanta Diabetes Associates

Atlanta, Georgia 30309

Principal Investigator: David Robertson, MD

from

Atlanta, GA

John Hopkins Bayview Medical Center

Baltimore, Maryland 21224

Principal Investigator: Pankaj Pascricha, MD

Phone: 410-550-6871

from

Baltimore, MD

Delta Research Partners, LLC

Bastrop, Louisiana 71220

Principal Investigator: Bal Raj Bhandari, MD

from

Bastrop, LA

University of Vermont Medical Center

Burlington, Vermont 05405

Principal Investigator: Peter Moses, MD

Phone: 802-656-9912

from

Burlington, VT

Charlottesville Medical Research Inc.

Charlottesville, Virginia 22911

Principal Investigator: Daniel Pambianco, MD

from

Charlottesville, VA

ClinSearch, LLC

Chattanooga, Tennessee 37421

Principal Investigator: Richard Krause, MD

Phone: 423-698-4584

from

Chattanooga, TN

GW Research Inc,

Chula Vista, California 91910

Principal Investigator: Gregory Wiener, MD

from

Chula Vista, CA

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky 41017

Principal Investigator: Michael Jones, MD

Phone: 859-341-3575

from

Crestview Hills, KY

iResearch Atlanta LLC

Decatur, Georgia 30030

Principal Investigator: Kimball Johnson, MD

from

Decatur, GA

Texas Tech University Health Sciences Center

415 East Yandell Drive
El Paso, Texas 79905

Principal Investigator: Richard McCallum, MD

Phone: 915-215-6505

from

El Paso, TX

Denver Esophageal and Stomach Center

Englewood, Colorado 80110

Principal Investigator: Ashwin Kurian, MD

Phone: 720-508-8855

from

Englewood, CO

Medisphere Medical Research Center

Evansville, Indiana 47714

Principal Investigator: Alexander Dela Llana, MD

from

Evansville, IN

Gastro One

Germantown, Tennessee 38138

Principal Investigator: Ziad Younes, MD

Phone: 901-820-0090

from

Germantown, TN

Desert Endocrinology Clinical Research Center

Henderson, Nevada 89052

Principal Investigator: William Reid Litchfield, MD

from

Henderson, NV

International Research Associates, LLC

Hialeah, Florida 33012

Principal Investigator: Luis C. Quintero, MD

Phone: 305-670-8830

from

Hialeah, FL

Houston Methodist Hospital

6550 Fannin St
Houston, Texas 77030

(713) 790-3311

Principal Investigator: Eamonn Quigley, MD

Phone: 713-441-0853

Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...

from

Houston, TX

Spring Gastroenterology

Humble, Texas 77338

Principal Investigator: Ravi Moparty, MD

from

Humble, TX

Grand Teton Research Group

Idaho Falls, Idaho 83404

Principal Investigator: Todd Williams, MD

from

Idaho Falls, ID

Indiana University Health

Indianapolis, Indiana 46202

Principal Investigator: John Wo, MD

Phone: 317-948-9227

from

Indianapolis, IN

Nature Coast Research

Inverness, Florida 34452

Principal Investigator: Paul Hellstern, MD

Phone: 352-341-2100

from

Inverness, FL

Clinical Research Solutions

Jackson, Tennessee 38305

Principal Investigator: Bob Souder, MD

from

Jackson, TN

University of Kansas Medical Center

3901 Rainbow Blvd
Kansas City, Kansas 66160

(913) 588-5000

Principal Investigator: Tuba Esfandyari, MD

Phone: 913-588-3934

University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...

from

Kansas City, KS

Florida Center for Gastroenterology Research

Largo, Florida 33777

Principal Investigator: Michael Schulman, MD

Phone: 727-544-1600

from

Largo, FL

Preferred Research Partners, Inc.

Little Rock, Arkansas 72211

Principal Investigator: John Baber, MD

Phone: 501-553-9987

from

Little Rock, AR

VA Long Beach Healthcare System

Long Beach, California 90822

Principal Investigator: Mazen Jamal, MD

Phone: 562-826-5058

from

Long Beach, CA

University of Louisville

500 S Preston St
Louisville, Kentucky

(502) 852-5555

Principal Investigator: Thomas Abell, MD

Phone: 502-540-1428

University of Louisville The University of Louisville is a state supported research university located in...

from

Louisville, KY

Manassas Clinical Research Center

Manassas, Virginia 20110

Principal Investigator: Nabil Andrawis, MD

from

Manassas, VA

Future Clinical Research

Miami, Florida 33122

Principal Investigator: Raul Tamayo, MD

from

Miami, FL

Baptist Diabetes Associates Research

Miami, Florida 33156

Principal Investigator: Peter Weissman, MD

from

Miami, FL

PharmaSouth Research

Miami, Florida 33175

Principal Investigator: Ricardo Presas, MD

from

Miami, FL

Quality Medical Research Pllc

Nashville, Tennessee 37211

Principal Investigator: Robert Herring, MD

Phone: 615-835-4750

from

Nashville, TN

Gastrointestinal and Liver Specialists of Tidewater

Norfolk, Virginia 23502

Principal Investigator: Syed Thiwan, MD

Phone: 757-466-0165

from

Norfolk, VA

Arkansas Gastroenterology

North Little Rock, Arkansas

Principal Investigator: Robert Murphy, MD

from

North Little Rock, AR

Advanced Research Institute

Ogden, Utah 84405

Principal Investigator: John Lowe, MD

Phone: 801-409-2040

from

Ogden, UT

Phoenix Medical Research, Inc.

Peoria, Arizona 85381

Principal Investigator: Robert Orr, MD

from

Peoria, AZ

Temple University Hospital

3401 N Broad St
Philadelphia, Pennsylvania

(215) 707-2000

Principal Investigator: Henry Parkman, MD

Phone: 215-707-9639

Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...

from

Philadelphia, PA

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota 55446

Principal Investigator: April Grudell, MD

Phone: 612-870-5587

from

Plymouth, MN

University Hospital in Pilsen

Plzen, 31200

Principal Investigator: Vaclav Hejda, MD

Phone: 00420 604 773 724

from

Plzen,

Advanced Medical Research

Port Orange, Florida 32127

Principal Investigator: Ammar Hemaiden, MD

Phone: 386-767-8800

from

Port Orange, FL

Northwest Gastroenterology Clinic, LLC

Portland, Oregon 97210

Principal Investigator: William R. Bennetts, MD

Phone: 503-229-7181

from

Portland, OR

Premier Medical Group of the Hudson Valley

243 N Rd
Poughkeepsie, New York 12601

(845) 471-9410

Principal Investigator: Peter Varunok, MD

Phone: 845-471-9410

Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...

from

Poughkeepsie, NY

Dominion Medical Associates

Richmond, Virginia 23219

Principal Investigator: Richard Jackson, MD

from

Richmond, VA

Pmg Research Of Salisbury

Salisbury, North Carolina 28144

Principal Investigator: Kiran Jagarlamudi, MD

from

Salisbury, NC

Digestive Research Center Gastroenterology Consultants of San Antonio

San Antonio, Texas 78215

Principal Investigator: Ravi Ganeshappa, MD

from

San Antonio, TX

Precision Research Institute, LLC

San Diego, California 92115

Principal Investigator: Taddese Desta, MD

from

San Diego, CA

Spring Family Clinic

Spring, Texas 77379

Principal Investigator: Sushma Gorrela, MD

from

Spring, TX

Options Health Research, Llc

Tusla, Oklahoma 74104

Principal Investigator: Harvey Tatum, MD

Phone: 918-513-3490

from

Tusla, OK

Veterans Medical Center

West Roxbury, Massachusetts 02132

Principal Investigator: Hiroshi Mashimo, MD, PhD

from

West Roxbury, MA

Professional Research Network of Kansas

Wichita, Kansas 67203

Principal Investigator: Dennis K. Buth, MD

Phone: 316-838-7700

from

Wichita, KS

Trial Management Associates LLC

Wilmington, North Carolina 28403

Principal Investigator: Robert Henihan, MD

from

Wilmington, NC

PMG Research of Winston-Salem

1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103

(336) 768-8062

Principal Investigator: Robert Holmes, MD

PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...

from

Winston-Salem, NC

Gastroenterology Associates of Western Michigan

Wyoming, Michigan 49519

Principal Investigator: Allan Coates, MD

Phone: 616-328-5319

from

Wyoming, MI

The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study

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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis

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