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

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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

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
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Largo, Florida 33777
Principal Investigator: Michael Schulman, MD
Phone: 727-544-1600
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
Principal Investigator: Donato R. Ricci, MD
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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,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Braden Kuo, MD
Phone: 617-726-0196
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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...
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix Tiongco, MD
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Arlington, Texas 76012
Principal Investigator: M. Tarek Al-Assi, MD
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Athens, Georgia 30607
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Atlanta, Georgia 30309
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Baltimore, Maryland 21224
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Phone: 410-550-6871
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Bastrop, Louisiana 71220
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Burlington, Vermont 05405
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Charlottesville, Virginia 22911
Principal Investigator: Daniel Pambianco, MD
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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Chula Vista, California 91910
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Crestview Hills, Kentucky 41017
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Decatur, Georgia 30030
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415 East Yandell Drive
El Paso, Texas 79905
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Englewood, Colorado 80110
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Evansville, Indiana 47714
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Germantown, Tennessee 38138
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Henderson, Nevada 89052
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Hialeah, Florida 33012
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Phone: 305-670-8830
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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...
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Humble, Texas 77338
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46202
Principal Investigator: John Wo, MD
Phone: 317-948-9227
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Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
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Jackson, Tennessee 38305
Principal Investigator: Bob Souder, MD
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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...
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Little Rock, Arkansas 72211
Principal Investigator: John Baber, MD
Phone: 501-553-9987
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Long Beach, California 90822
Principal Investigator: Mazen Jamal, MD
Phone: 562-826-5058
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Thomas Abell, MD
Phone: 502-540-1428
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Manassas, Virginia 20110
Principal Investigator: Nabil Andrawis, MD
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Miami, Florida 33122
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Miami, Florida 33156
Principal Investigator: Peter Weissman, MD
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Miami, Florida 33175
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Nashville, Tennessee 37211
Principal Investigator: Robert Herring, MD
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Norfolk, Virginia 23502
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North Little Rock, Arkansas
Principal Investigator: Robert Murphy, MD
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Ogden, Utah 84405
Principal Investigator: John Lowe, MD
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Peoria, Arizona 85381
Principal Investigator: Robert Orr, MD
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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...
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Plymouth, Minnesota 55446
Principal Investigator: April Grudell, MD
Phone: 612-870-5587
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Plzen, 31200
Principal Investigator: Vaclav Hejda, MD
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Port Orange, Florida 32127
Principal Investigator: Ammar Hemaiden, MD
Phone: 386-767-8800
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Portland, Oregon 97210
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Phone: 503-229-7181
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Peter Varunok, MD
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Richmond, Virginia 23219
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Salisbury, North Carolina 28144
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San Antonio, Texas 78215
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San Diego, California 92115
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Spring, Texas 77379
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Tusla, Oklahoma 74104
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West Roxbury, Massachusetts 02132
Principal Investigator: Hiroshi Mashimo, MD, PhD
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Wichita, Kansas 67203
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Wilmington, North Carolina 28403
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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Wyoming, Michigan 49519
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