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

Use our guide to learn which trials are right for you!

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
60
sites
Decatur, Georgia 30030
Principal Investigator: Kimball Johnson, MD
?
mi
from
Decatur, GA
Click here to add this to my saved trials
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,...
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
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,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Braden Kuo, MD
Phone: 617-726-0196
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix Tiongco, MD
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Arlington, Texas 76012
Principal Investigator: M. Tarek Al-Assi, MD
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Jeffrey Williams, MD
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
Principal Investigator: David Robertson, MD
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21224
Principal Investigator: Pankaj Pascricha, MD
Phone: 410-550-6871
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bastrop, Louisiana 71220
Principal Investigator: Bal Raj Bhandari, MD
?
mi
from
Bastrop, LA
Click here to add this to my saved trials
Burlington, Vermont 05405
Principal Investigator: Peter Moses, MD
Phone: 802-656-9912
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Principal Investigator: Daniel Pambianco, MD
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Principal Investigator: Richard Krause, MD
Phone: 423-698-4584
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48098
Principal Investigator: Ronald Fogel, MD
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chula Vista, California 91910
Principal Investigator: Gregory Wiener, MD
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
Principal Investigator: Michael Jones, MD
Phone: 859-341-3575
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
415 East Yandell Drive
El Paso, Texas 79905
Principal Investigator: Richard McCallum, MD
Phone: 915-215-6505
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Englewood, Colorado 80110
Principal Investigator: Ashwin Kurian, MD
Phone: 720-508-8855
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Evansville, Indiana 47714
Principal Investigator: Alexander Dela Llana, MD
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Ziad Younes, MD
Phone: 901-820-0090
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Henderson, Nevada 89052
Principal Investigator: William Reid Litchfield, MD
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33012
Principal Investigator: Luis C. Quintero, MD
Phone: 305-670-8830
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Humble, Texas 77338
Principal Investigator: Ravi Moparty, MD
?
mi
from
Humble, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Todd Williams, MD
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: John Wo, MD
Phone: 317-948-9227
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson, Tennessee 38305
Principal Investigator: Bob Souder, MD
?
mi
from
Jackson, TN
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Largo, Florida 33777
Principal Investigator: Michael Schulman, MD
Phone: 727-544-1600
?
mi
from
Largo, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72211
Principal Investigator: John Baber, MD
Phone: 501-553-9987
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90822
Principal Investigator: Mazen Jamal, MD
Phone: 562-826-5058
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
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...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis, MD
?
mi
from
Manassas, VA
Click here to add this to my saved trials
Miami, Florida 33122
Principal Investigator: Raul Tamayo, MD
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33156
Principal Investigator: Peter Weissman, MD
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33175
Principal Investigator: Ricardo Presas, MD
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37211
Principal Investigator: Robert Herring, MD
Phone: 615-835-4750
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia 23502
Principal Investigator: Syed Thiwan, MD
Phone: 757-466-0165
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
North Little Rock, Arkansas
Principal Investigator: Robert Murphy, MD
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Ogden, Utah 84405
Principal Investigator: John Lowe, MD
Phone: 801-409-2040
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Peoria, Arizona 85381
Principal Investigator: Robert Orr, MD
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plymouth, Minnesota 55446
Principal Investigator: April Grudell, MD
Phone: 612-870-5587
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
Plzen, 31200
Principal Investigator: Vaclav Hejda, MD
Phone: 00420 604 773 724
?
mi
from
Plzen,
Click here to add this to my saved trials
Port Orange, Florida 32127
Principal Investigator: Ammar Hemaiden, MD
Phone: 386-767-8800
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Portland, Oregon 97210
Principal Investigator: William R. Bennetts, MD
Phone: 503-229-7181
?
mi
from
Portland, OR
Click here to add this to my saved trials
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...
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Richmond, Virginia 23219
Principal Investigator: Richard Jackson, MD
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Salisbury, North Carolina 28144
Principal Investigator: Kiran Jagarlamudi, MD
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
San Antonio, Texas 78215
Principal Investigator: Ravi Ganeshappa, MD
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92115
Principal Investigator: Taddese Desta, MD
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Spring, Texas 77379
Principal Investigator: Sushma Gorrela, MD
?
mi
from
Spring, TX
Click here to add this to my saved trials
Tusla, Oklahoma 74104
Principal Investigator: Harvey Tatum, MD
Phone: 918-513-3490
?
mi
from
Tusla, OK
Click here to add this to my saved trials
West Roxbury, Massachusetts 02132
Principal Investigator: Hiroshi Mashimo, MD, PhD
?
mi
from
West Roxbury, MA
Click here to add this to my saved trials
Wichita, Kansas 67203
Principal Investigator: Dennis K. Buth, MD
Phone: 316-838-7700
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28403
Principal Investigator: Robert Henihan, MD
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
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...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Wyoming, Michigan 49519
Principal Investigator: Allan Coates, MD
Phone: 616-328-5319
?
mi
from
Wyoming, MI
Click here to add this to my saved trials