A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04



Status:Recruiting
Conditions:Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:December 19, 2017
End Date:September 28, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877‐277‐8566

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

A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants
with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic
gastroparesis.


Inclusion Criteria:

- Two different groups of participants may enter into the study:

- Participants must meet all the inclusion criteria at screening (Visit 1) and at the
end of the Run-in Period (Visit 3) for randomization into the Treatment Period of
RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with
dosing,entry of diary data into the DGSSD during the lead-in study Run-in Period)
during the lead-in study Run-in Period at the end of the lead-in study Run-in Period,
are eligible for randomization in Study RLM-MD-04 if:

- 1) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS
≥ 12 at the end of the lead-in study Run-in Period.

OR

- 2) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of
≥ 12 and < 16 at the end of the lead-in study Run-in Period.

In the current study, these "rollover participants" will enter the study at Visit 1
(Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1)
procedures

Patients who undergo screening and run-in procedures in Study RLM-MD-04 are "de novo
participants". To be eligible for randomization in the current study, de novo participants
must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including:

1. At Screening, be male or female age 18 years and older, with BMI > 18.5 kg/m2; T1DM or
T2DM with controlled and stable blood glucose levels and HbA1c ≤ 11%; symptoms
suggestive of DG for at least 3 months (one of which must be nausea), with mechanical
obstruction of the GI tract as the cause of symptoms having been ruled out; delayed GE
by gastric emptying breath test (GEBT).

2. After Run-in Period: Evidence of compliance during the Run-in Period with the use of
the electronic hand-held device for entry of data, with twice daily SC injections of
the study treatment, and no treatment with GI promotility agents; a score of ≥ 12 for
the average of the daily DGSSS measured during the Run-in Period.

Exclusion Criteria:

- There are no exclusion criteria specific to this study; participants will be excluded
from this study if any of the exclusion criteria apply at screening (Visit 1) and at
the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of
studies RLM-MD-01 and RLM-MD-02, except as specified in the inclusion criteria
We found this trial at
182
sites
11914 Astoria Boulevard
Houston, Texas 77089
?
mi
from
Houston, TX
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
2147 Northeast Coachman Road
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
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...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
1800 SW 1 ST #208
Miami, Florida 33135
?
mi
from
Miami, FL
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
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...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Athens, Alabama 35811
?
mi
from
Athens, AL
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78704
?
mi
from
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Beavercreek, Ohio 45440
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Blue Ridge, Georgia 30513
?
mi
from
Blue Ridge, GA
Click here to add this to my saved trials
Brick, New Jersey 08723
?
mi
from
Brick, NJ
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Bristol, Connecticut 06010
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
555 Old Norcross Road
Buford, Georgia 30519
?
mi
from
Buford, GA
Click here to add this to my saved trials
Canoga Park, California 91303
?
mi
from
Canoga Park, CA
Click here to add this to my saved trials
Carnesville, Georgia 30521
?
mi
from
Carnesville, GA
Click here to add this to my saved trials
1525 West Caro Road
Caro, Michigan 48723
?
mi
from
Caro, MI
Click here to add this to my saved trials
6300 Stonewood Drive
Carrollton, Texas 75007
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
850 North Kolb Road
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
6035 Shallowford Road
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Cleveland, Ohio 44109
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
9701 Euclid Avenue
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21045
?
mi
from
Columbia, MD
Click here to add this to my saved trials
4400 North High Street
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
72 West 3rd Avenue
Columbus, Ohio 43201
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Cooper City, Florida 33024
?
mi
from
Cooper City, FL
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
Costa Mesa, California 92627
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
Cutler Bay, Florida 33157
?
mi
from
Cutler Bay, FL
Click here to add this to my saved trials
Cutler Bay, Florida 33189
?
mi
from
Cutler Bay, FL
Click here to add this to my saved trials
Davidson, North Carolina 28036
?
mi
from
Davidson, NC
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
480 Honeysuckle Road
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
El Cajon, California 92020
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Encinitas, California 92024
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Englewood, Colorado 80110
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Erlanger, KY
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
1201 Flushing Road
Flint, Michigan 48504
?
mi
from
Flint, MI
Click here to add this to my saved trials
Foley, Alabama 36535
?
mi
from
Foley, AL
Click here to add this to my saved trials
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
1324 Wolf Park Drive
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
?
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27410
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
6700 East Davison Street
Hamtramck, Michigan 48212
?
mi
from
Hamtramck, MI
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
830 North Krome Avenue
Homestead, Florida 33030
?
mi
from
Homestead, FL
Click here to add this to my saved trials
Houma, Louisiana 70360
?
mi
from
Houma, LA
Click here to add this to my saved trials
1 Baylor Plaza
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77083
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Inverness, Florida 34452
?
mi
from
Inverness, FL
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
33-57 Harrison Street
Johnson City, New York 13790
?
mi
from
Johnson City, NY
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
1 Lakeshore Drive
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
2755 East Desert Inn Road
Las Vegas, Nevada 89121
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89128
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Levittown, Pennsylvania 19056
?
mi
from
Levittown, PA
Click here to add this to my saved trials
1 Saint Vincent Circle
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials