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
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Chapel Hill, North Carolina 27599
(919) 962-2211
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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
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Albuquerque, New Mexico 87108
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Arlington, Texas 76012
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13001 E. 17th Pl
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303-724-5000
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Austin, Texas 78704
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Brockton, Massachusetts 02302
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555 Old Norcross Road
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850 North Kolb Road
Chandler, Arizona 85224
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72 West 3rd Avenue
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410 W 10th Ave
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425 Centre View Boulevard
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Cumberland, Rhode Island 02864
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1201 Flushing Road
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Foley, Alabama 36535
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200 Hawkins Dr,
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9500 Gilman Dr
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500 S Preston St
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