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

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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
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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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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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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Anaheim, California 92801
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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
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Austin, Texas 78704
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Aventura, Florida 33180
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555 Old Norcross Road
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1525 West Caro Road
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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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410 W 10th Ave
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Concord, North Carolina 28025
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200 Hawkins Dr,
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3901 Rainbow Blvd
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9500 Gilman Dr
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