A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03



Status:Enrolling by invitation
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:January 24, 2018
End Date:December 6, 2020

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A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

A 46-week study to compare the efficacy of relamorelin with that of placebo in participants
with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants
will either continue on relamorelin or placebo for 6 additional weeks.


Inclusion Criteria:

- Participants are eligible to be included in the study only if all the following
criteria apply:

- Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01
(NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study

- Able to provide written informed consent (IC) prior to any study procedures and
willing and able to comply with study procedures

- In the opinion of the investigator, the participant demonstrated adequate compliance
with the study procedures in Study RLM-MD-01 or RLM-MD-02

Exclusion Criteria:

- Participants are excluded from the study if any of the following criteria apply:

- Participant is not willing or able to abide by the restrictions regarding concomitant
medicine use

- Participant is planning to receive an investigational drug (other than study
treatment) or investigational device at any time during Study RLM-MD-03

- Participant has an unresolved adverse event (AE) or a clinically significant finding
on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG)
that, in the investigator's opinion, would limit the participant's ability to
participate in or complete the study

- Any other reason that, in the investigator's opinion, would confound proper
interpretation of the study or expose a participant to unacceptable risk, including
renal, hepatic or cardiopulmonary disease
We found this trial at
173
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109 Crossroads Road
Scottdale, Pennsylvania 15683
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
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1800 SW 1 ST #208
Miami, Florida 33135
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Albuquerque, New Mexico 87108
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Arlington, Texas 76012
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Asheville, North Carolina 28801
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Athens, Alabama 35811
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Atlanta, Georgia 30309
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Austin, Texas 78704
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Bastrop, Louisiana 71220
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Beavercreek, Ohio 45440
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Blue Ridge, Georgia 30513
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Brick, New Jersey 08723
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Bridgeport, Connecticut 06606
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Brockton, Massachusetts 02302
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555 Old Norcross Road
Buford, Georgia 30519
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Canoga Park, California 91303
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Carnesville, Georgia 30521
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6300 Stonewood Drive
Carrollton, Texas 75007
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850 North Kolb Road
Chandler, Arizona 85224
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28204
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6035 Shallowford Road
Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48098
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Chula Vista, California 91910
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Clearwater, Florida 33756
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Cleveland, Ohio 44109
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9701 Euclid Avenue
Cleveland, Ohio 44195
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Colorado Springs, Colorado 80907
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Columbia, Maryland 21045
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72 West 3rd Avenue
Columbus, Ohio 43201
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4400 North High Street
Columbus, Ohio 43214
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, Ohio 43213
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Cooper City, Florida 33024
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Costa Mesa, California 92627
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425 Centre View Boulevard
Crestview Hills, Kentucky 41017
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Cumberland, Rhode Island 02864
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Cutler Bay, Florida 33157
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Davidson, North Carolina 28036
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Decatur, Georgia 30030
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480 Honeysuckle Road
Dothan, Alabama 36305
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Egg Harbor Township, New Jersey 08234
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El Cajon, California 92020
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Encinitas, California 92024
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Englewood, Colorado 80110
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Evanston, Illinois 60201
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Evansville, Indiana 47714
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Fairfax, Virginia 22031
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Fayetteville, North Carolina 28304
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1201 Flushing Road
Flint, Michigan 48504
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Foley, Alabama 36535
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1324 Wolf Park Drive
Germantown, Tennessee 38138
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Glen Burnie, Maryland 21061
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Greensboro, North Carolina 27410
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Greenville, South Carolina 29615
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Hagerstown, Maryland 21740
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6700 East Davison Street
Hamtramck, Michigan 48212
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Hialeah, Florida 33016
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830 North Krome Avenue
Homestead, Florida 33030
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Houma, Louisiana 70360
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Houston, Texas 77083
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11914 Astoria Boulevard
Houston, Texas 77089
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1 Baylor Plaza
Houston, Texas 77030
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Inverness, Florida 34452
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32216
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Jeffersonville, Indiana 47130
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33-57 Harrison Street
Johnson City, New York 13790
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
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Lancaster, California 93534
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2755 East Desert Inn Road
Las Vegas, Nevada 89121
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Las Vegas, Nevada 89102
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Las Vegas, Nevada 89128
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Levittown, Pennsylvania 19056
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1 Saint Vincent Circle
Little Rock, Arkansas 72205
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Little Rock, Arkansas 72212
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