Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02

Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT03426345
Collaborator
(none)
311
240
2
28.9
1.3
0

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Actual Study Start Date :
Feb 16, 2018
Actual Primary Completion Date :
Jul 16, 2020
Actual Study Completion Date :
Jul 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

Drug: Placebo
Placebo injected subcutaneously twice daily.

Experimental: Relamorelin 10 μg

Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.

Drug: Relamorelin
Relamorelin 10 μg injected twice daily for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) [Baseline (Day-14 to Day-1) to Week 12]

    Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.

  2. Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Week 6 to Week 12]

    The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.

Secondary Outcome Measures

  1. Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) to (Week 6 to Week 12)]

    A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.

  2. Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) to (Week 6 to Week 12)]

    An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.

  3. Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) to (Week 6 to Week 12)]

    A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.

  4. Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period [Baseline (Day-14 to Day-1) to (Week 6 to Week 12)]

    A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).

  5. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) [Up to approximately 16 weeks]

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.

  6. Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results [Up to 12 weeks]

    Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  7. Number of Participants With Clinically Meaningful Trends for Vital Signs [Up to 12 weeks]

    Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.

  8. Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results [Up to 12 weeks]

    A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

  9. Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [Baseline (Day 1) up to 12 weeks]

  10. Number of Participants With Anti-relamorelin Antibody Testing Results by Visit [Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)]

    A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of Type 1 or Type 2 diabetes mellitus

  • Meet the per protocol criteria of diabetic gastroparesis

  • Compliance with diary

  • Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:
  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube

  • Actively experiencing anorexia nervosa, binge-eating, bulimia or other eating disorder at the time of Screening (Visit 1)

  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity

  • History of gastrointestinal disorders that may be similar to gastroparesis

  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Alabama Research Center, LLC Athens Alabama United States 35611
2 Synexus Clinical Research US - Simon Williamson Clinic Birmingham Alabama United States 35211
3 G & L Research, LLC Foley Alabama United States 36535
4 Alabama Medical Group, PC Mobile Alabama United States 36608
5 Synexus Clinical Research US, Inc. Tucson Arizona United States 85741
6 Applied Research Center of Arkansas Little Rock Arkansas United States 72212
7 Unity Health - Searcy Medical Center Searcy Arkansas United States 72143
8 GW Research Inc. Chula Vista California United States 91910
9 Diagnamics Inc. Encinitas California United States 92024
10 Fresno Clinical Research Center Fresno California United States 93720
11 Torrance Clinical Research Institute, Inc. Lomita California United States 90717
12 Tibor Rubin VA Medical Center Long Beach California United States 90822
13 Angel City Research Inc. Los Angeles California United States 90026
14 Facey Medical Foundation Mission Hills California United States 91345
15 United Medical Doctors Murrieta California United States 92563
16 Stanford Hospital, Digestive Health Clinic Palo Alto California United States 94304
17 TriWest Research Associates Poway California United States 92064
18 Optimal Research California San Diego California United States 92108
19 Syrentis Clinical Research Santa Ana California United States 92705
20 New Hope Research Development Whittier California United States 90603
21 Synexus Clinical Research US, Inc. - Colorado Springs Family Practice Colorado Springs Colorado United States 80909
22 Gastroenterology Associates of Fairfield County, P.C. Bridgeport Connecticut United States 06824
23 Visionary Investigators Network Aventura Florida United States 33180
24 Clinical Research of West Florida Clearwater Florida United States 33765
25 ALL Medical Research LLC Cooper City Florida United States 33024
26 Palmetto Research, LLC Hialeah Florida United States 33016
27 Vida Clinical Trials Homestead Florida United States 33030
28 Sanchez Clinical Research, Inc. Miami Florida United States 33157
29 Gastroenterology Group of Naples Naples Florida United States 34102
30 Synexus Pinellas Park Florida United States 33781
31 Cleveland Clinic Florida - Weston Weston Florida United States 33331
32 Atlanta Diabetes Associates Atlanta Georgia United States 30318
33 Emory University Atlanta Georgia United States 30322
34 River Birch Research Alliance, LLC Blue Ridge Georgia United States 30513
35 Gwinnett Research Institute, LLC Buford Georgia United States 30519
36 iResearch Atlanta LLC Decatur Georgia United States 30030
37 Clinical Research Consultants of Atlanta Suwanee Georgia United States 30024
38 Rocky Mountain Diabetes and Osteoporosis Center, PA Idaho Falls Idaho United States 83404-7596
39 Synexus Clinical Research US, Inc. Chicago Illinois United States 60602
40 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
41 North Shore University Health System Evanston Illinois United States 60201
42 American Research, LLC Jeffersonville Indiana United States 47130
43 Gastroenterology of Southern Indiana New Albany Indiana United States 47150
44 Health Science Research Center Pratt Kansas United States 67124
45 WestGlen Gastrointestinal Consultants Shawnee Mission Kansas United States 67214
46 Kansas Medical Clinic Topeka Kansas United States 66606
47 Professional Research Network of Kansas, LLC Wichita Kansas United States 67205
48 Via Christi Clinic, PA Wichita Kansas United States 67208
49 Tri-State Gastroenterology Crestview Hills Kentucky United States 41017
50 WK Physicians Network Bossier City Louisiana United States 71111
51 Avant Research Associates LLC Crowley Louisiana United States 70526
52 Clinical Trials of SWLA, LLC Lake Charles Louisiana United States 70601
53 Tandem Clinical Research Marrero Louisiana United States 70072
54 Clinical Trials of America, Inc. West Monroe Louisiana United States 71291
55 Trialspark - Sood Bowie Maryland United States 20716
56 Capital Diabetes and Endocrine Associates Camp Springs Maryland United States 20746
57 Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
58 Woodholme Gastroenterology Associates, P.A. Glen Burnie Maryland United States 21061
59 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
60 Meridian Clinical Research, LLC Rockville Maryland United States 20854
61 Commonwealth Clinical Studies, PLLC. Brockton Massachusetts United States 02302
62 Clinical Research Institute of Michigan Chesterfield Michigan United States 48047
63 Aa Mrc Llc Flint Michigan United States 48504
64 Washington University in St. Louis Saint Louis Missouri United States 63110
65 Synexus Clinical Research US, Inc Saint Louis Missouri United States 63141
66 Heartland Clinical Research, Inc Omaha Nebraska United States 68134
67 USMA Clinical Research, LLC Elizabeth New Jersey United States 07201
68 Lovelace Scientific Resources, Inc. Albuquerque New Mexico United States 87108
69 Synexus Clinical Research US, Inc. Jamaica New York United States 11432
70 Winthrop-University Hospital Mineola New York United States 11501
71 Carolina Digestive Health Associates, PA Davidson North Carolina United States 28036
72 Kinston Medical Specialists, P.A. Kinston North Carolina United States 28501
73 Diabetes and Endocrinology Consultants, PC Morehead City North Carolina United States 28557
74 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
75 PMG Research of Winston-Salem, LLC Winston-Salem North Carolina United States 27103
76 Synexus Clinical Research US, Inc. Akron Ohio United States 44311
77 Diabetes & Endocrinology Associates of Stark County, Inc. Canton Ohio United States 44718
78 Synexus Clinical Research US - Cincinnati Cincinnati Ohio United States 45236
79 Synexus Clinical Research US, Inc Cincinnati Ohio United States 45249
80 The MetroHealth System MHS Cleveland Ohio United States 44109-1998
81 Digestive Disease & Surgery Institute Cleveland Ohio United States 44195
82 The Ohio State University, Wexner Medical Center Columbus Ohio United States 43203
83 Aventiv Research, Inc. Columbus Ohio United States 43213
84 CIC America Clinical Inquest Center Ltd. Dayton Ohio United States 45409
85 Hometown Urgent Care and Research Dayton Ohio United States 45424
86 Centennial Health-Synexus Oklahoma City Oklahoma United States 73111
87 Options Health Research, LLC Tulsa Oklahoma United States 74104
88 University of Pennsylvania Philadelphia Pennsylvania United States 19104
89 Allegheny Endocrinology Associates Pittsburgh Pennsylvania United States 15212
90 Guthrie Clinical Research Sayre Pennsylvania United States 18840
91 Frontier Clinical Research, LLC Smithfield Pennsylvania United States 15478
92 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
93 Care Access Research Warwick Rhode Island United States 02886
94 Synexus Clinical Research US, Inc. Anderson South Carolina United States 29621
95 Clinical Trials of South Carolina Charleston South Carolina United States 29406
96 Health Concepts Rapid City South Dakota United States 57702
97 Clinsearch Chattanooga Tennessee United States 37421
98 Gastro One Germantown Tennessee United States 38138
99 East Tennessee Research Institute Johnson City Tennessee United States 37604
100 Texas Clinical Research Institute, LLC Arlington Texas United States 76012
101 ClinRx Research, LLC Carrollton Texas United States 75007
102 Baylor College of Medicine Medical Center Houston Texas United States 77030
103 Biopharma Informatic Inc., Research Center Houston Texas United States 77043
104 Houston Endoscopy and Research Center, Inc. Houston Texas United States 77079
105 Rodriguez Clinical Trials Houston Texas United States 77083
106 Sante Clinical Research Kerrville Texas United States 78028
107 Pinnacle Clinical Research San Antonio Texas United States 78215
108 Synexus Clinical Research US, Inc. San Antonio Texas United States 78229
109 Digestive & Liver Disease Center of San Antonio, PLLC San Antonio Texas United States 78233
110 Dwayne O. Williams MD Sugar Land Texas United States 77479
111 Blue Ridge Medical Research Lynchburg Virginia United States 24502
112 Manassas Clinical Research Centre Manassas Virginia United States 20110
113 VA Medical Center McGuire VAMC Richmond Virginia United States 23249
114 Washington Gastroenterology PLLC Tacoma Washington United States 98405
115 Maffei Centro Medico-Investigacion Clinica Aplicada C.a.b.a. Buenos Aires Province Argentina C1425AGC
116 Hospital Sirio Libanes Caba Buenos Aires Province Argentina C1419AHN
117 Centro de Investigaciones Medicas Mar del Plata SRL Mar del Plata Buenos Aires Province Argentina B7600FYK
118 Instituto Privado de Investigaciones Clínicas de Córdoba Córdoba Cordoba Argentina X5000AAW
119 Instituto de Investigaciones Clinicas de Rosario Rosario Santa Fe Argentina 2000
120 Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli Rosario Santa Fe Argentina S200CFK
121 Clinica Mayo - Infectious DiseasesClínica Mayo de Urgencias San Miguel de Tucuman Tucuman Argentina 4000
122 CIPREC Ciudad Autonoma de Buenos Aires Argentina 1119
123 Centro Universitario de Investigacion en Farmacologia Clinic Corrientes Argentina W3410AVV
124 CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian Córdoba Argentina X5000BNB
125 Ordination Sankt Stefan Steiermark Austria 8511
126 VIVIT Institute, am LKH Feldkirch Feldkirch Vorarlberg Austria 6807
127 Privatklinik Wehrle-Diakonissen Salzburg Austria 5020
128 Oö. Gesundheits- und Spitals-AG/LKH Steyr Steyr Austria 4400
129 AZ Sint Lucas Brugge Brugge Antwerpen Belgium 2650
130 Universitair Ziekenhuis Antwerpen, Gastro-Enterologie, Edegem Antwerp Belgium 2650
131 UZ Brussel Jette Brussel Belgium 1090
132 Hospital Universitario Walter Cantidio Fortaleza Ceara Brazil 60430-372
133 Centro de Pesquisa Clinica do Brasil Brasilia Distrito Federal Brazil 71625175
134 Hospital Universitario Joao de Barros Barreto Belem Para Brazil 66073-000
135 Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul Brazil 90430-001
136 Instituto Catarinense de Endocrinologia e Diabetes (ICED) Joinville Santa Catarina Brazil 89201-260
137 Scentryphar Pesquisa Clinica Ltda Campinas Sao Paulo Brazil 13020-431
138 Instituto de Pesquisa Clinica em Campinas Campinas Sao Paulo Brazil 13060-080
139 CPQuali Pesquisa Clinica Ltda Santa Cecília Sao Paulo Brazil 01228-000
140 Instituto de Estudos E Persquisas Clinicas do Ceará - IEP/CE - Oncology Fortaleza Brazil 60160-230
141 Instituto de Pesquisa ClÍnica e Medicina AvanCada Ltda SÃo Paulo Brazil 01223-001
142 University of Calgary Calgary Alberta Canada T2N 2T9
143 Alberta Diabetes Institute Edmonton Alberta Canada T6G 2E1
144 Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia Canada V5Z1M9
145 Eastern Health St. John's Newfoundland and Labrador Canada A1B 3V6
146 South Shore Medical Arts Bridgewater Nova Scotia Canada B4V 2V6
147 The Ottawa Hospital Ottawa Ontario Canada K1H 7W9
148 Sunnybrook Health Science Centre Toronto Ontario Canada M4N 3M5
149 Toronto Western Hospital, University Health Network Toronto Ontario Canada M5T 2S8
150 Toronto Liver Centre Toronto Ontario Canada M6H 3M1
151 Toronto Digestive Disease Associates Vaughan Ontario Canada L4L 4YZ
152 CISSS de la Monteregie-Centre Greenfield Park Quebec Canada J4V 2H1
153 Recherche GCP Research Montreal Quebec Canada H1M 1B1
154 Centre Hospitalier de l'Universite de Montreal - CHUM Montreal Quebec Canada H2X 0A9
155 Central Alberta Research Centre Red Deer Canada T4N 6V7
156 Centro Cardiovascular Colombiano Clínica Santa María Medellin Antioquia Colombia 050034
157 Rodrigo Botero S.A.S. Medellin Antioquia Colombia 50030
158 Centro Cardiovascular y de Diabetes Barranquilla Atlantico Colombia 080020
159 Fundacion Bios Barranquilla Atlantico Colombia 080020
160 Asociación Colombiana de Diabetes Bogotá Cundinamarca Colombia 111311
161 Healthy Medical Center Zipaquira Cundinamarca Colombia 250252
162 Medplus Mp Bogota Distrito Capital De Bogotá Colombia 110221
163 Endocare Ltda. Bogota Distrito Capital De Bogotá Colombia 111111
164 Fundacion Centro de Investigaciones Clinicas CARDIOMET Pereira Risaralda Colombia 660002
165 IPS Centro Medico Julian Coronel S.A Cali Valle Del Cauca Colombia 760035
166 Centro Medico Imbanaco de Cali S.A. Cali Valle Del Cauca Colombia 760042
167 Gastroenheden, Hvidovre hospital Hvidovre Copenhagen Denmark 2605
168 Endocrinology, Aalborg University Hospital Aalborg Denmark DK-9000
169 Center for Clinical Metabolic Research Hellerup Denmark 2900
170 Klinische Forschung Karlsruhe GmbH Karlsruhe Baden-SWürttemberg Germany 76199
171 Studienzentrum Schwittay Böhlen Saxony Germany 4564
172 Klinische Forschung Dresden GmbH Dresden Saxony Germany 1309
173 Clinical Research Unit Giessen Germany 32392
174 Clinical Research Hamburg Hamburg Germany 22143
175 Israelitisches Krankenhaus Hamburg Germany 22297
176 KRH Klinikum Siloah Hannover Germany 30459
177 Markhot Ferenc Oktatokorhaz es Rendelointezet Eger Heves Hungary H-3300
178 BKS Research Kft Synexus AS Hatvan Heves Hungary 3000
179 Hetenyi Geza Hospital Szolnok Jász-Nagykun-Szolnok Hungary H-5004
180 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Zala Hungary H-8900
181 Synexus Budapest DRS Budapest Hungary 1036
182 Strázsahegy Gyógyszertár Medicina Budapest Hungary H1171
183 SYNEXUS Magyarorszag Kft Debrecen A.S. Debrecen Hungary 4025
184 Synexus Magyarország kft. Gyula DRS Gyula Hungary 5700
185 Szegedi Tudomanyegyetem Szeged Hungary H-6720
186 Synexus Magyarorszag Kft Zalaegerszeg Hungary 8900
187 Polana-D Daugavpils Latvia 5401
188 Kraslava Hospital Kraslava Latvia 5601
189 Pauls Stradins Clinical University Hospital, Endokrinologijas nodala Riga Latvia 1002
190 Digestive Diseases Centre GASTRO Riga Latvia 1006
191 Medical and Nutritional Trials Cuauhtemoc Cdmx Mexico 06700
192 Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology Mexico Distrito Federal Mexico 11650
193 Centro de Atención e Investigación en Factores de Riesgo Car Mexico Distrito Federal Mexico 14000
194 Clinicos Asociados BOCM SC Portales Distrito Federal Mexico 03300
195 Unidad de Investigacion Clinica Cardiometabolica de Occidente Guadalajara Jalisco Mexico 44150
196 Consultorio Medico Guadalajara Jalisco Mexico C.P. 44210
197 Unidad de Investigación Clínica en Medicina S.C. Guadalajara Jalisco Mexico C.P. 44670
198 Centro de Desarrollo Biomedico S.C.P. Mérida Yucatan Mexico 97070
199 Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV Aguascalientes Mexico 20230
200 Hospital Cardiologica Aguascalientes Aguascalientes Mexico 20230
201 Dioderm Instituto de Investigacion Durango Mexico 34060
202 Sociedad de Metabolismo y Corazon, S.C. Veracruz Mexico C.P. 91900
203 Saint-Petersburg City Pokrovskaya Hospital St-Petersburg Leningrad Region Russian Federation 199106
204 Scientific Institute of Clinical and Experimental Lymphology Novosibirsk Novosibirsk Oblast Russian Federation 630117
205 GUZ Saratov City Clinical Hospital 9 Saratov Saratov Region Russian Federation 410030
206 Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko Nizhny Novgorod Volga Russian Federation 603126
207 Kazan State Medical University Kazan Russian Federation 420012
208 FSBI National medical endocrinology research centre Moscow Russian Federation 117036
209 Moscow Regional Research Clinical Institute named by MF Vladimirski Moscow Russian Federation 129110
210 Rostov on Don Rostov on Don Russian Federation 344019
211 Rostov State Medical University Rostov-on-Don Russian Federation 344022
212 North-Western State Medical University named after I. I. Mechnikov Saint-Petersburg Russian Federation 191015
213 Saratov City Clinical Hospital 12 Saratov Russian Federation 410039
214 FARMOVS Bloemfontein Free State South Africa 9301
215 Wits Clinical Research Johannesburg Gauteng South Africa 2193
216 Synexus Stanza Clinical Research Centre Pretoria Gauteng South Africa 0122
217 Watermeyer Clinical Research Site Silverton Gauteng South Africa 184
218 Synexus Helderberg Clinical Research Centre Cape Town Western Cape South Africa 7130
219 TREAD Research Cape Town South Africa 7500
220 MAC Clinical Research Manchester Manchester Greater Manchester United Kingdom M13 9NQ
221 Synexus Lancashire Dedicated Research Centre Chorley Lancashire United Kingdom PR7 7NA
222 Royal Oldham Hospital Oldham Lancashire United Kingdom OL1 2JH
223 MAC Research, Exchange House Cannock Staffordshire United Kingdom WS11 0BH
224 University Hospitals of North Midlands Stoke on Trent Staffordshire United Kingdom ST6 8DG
225 Royal Wolverhampton NHS Trust Wolverhampton West Midlands United Kingdom WV10 0QP
226 MAC Clinical Research, Monarch House Leeds West Yorkshire United Kingdom LS10 1DU
227 MAC Research Barnsley United Kingdom S75 3DL
228 MAC Clinical Research Blackpool United Kingdom FY2 0JH
229 Synexus Wales Clinical Research Centre Cardiff United Kingdom CF15 9SS
230 Mid Essex Hospital Services NHS Trust Broomfield Hospital Chelmsford United Kingdom CM1 7ET
231 Western General Hospital Edinburgh United Kingdom EH4 2XU
232 Synexus Merseyside Dedicated Research Centre Liverpool United Kingdom L22 0LG
233 MAC Clinical Research Liverpool United Kingdom L34 1BH
234 Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital London United Kingdom E1 2AJ
235 MAC Clinical Research, GAC House Manchester United Kingdom M13 9NQ
236 Synexus Manchester Clinical Research Centre Manchester United Kingdom M15 6SX
237 Royal Victoria Infirmary: Clinical Research Facility Newcastle upon Tyne United Kingdom NE7 7DN
238 Biomedical Research Centre Nottingham United Kingdom NG7 2UH
239 Synexus Hexham Dedicated Research Centre Stockton-on-Tees United Kingdom TS19 8PE
240 Synexus North Tees Clinical Research Centre Stockton-on-Tees United Kingdom TS19 8PE

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: Wieslaw (Wes) Bochenek, MD, PhD, Allergan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03426345
Other Study ID Numbers:
  • RLM-MD-02
  • 2017-002177-20
First Posted:
Feb 8, 2018
Last Update Posted:
Aug 6, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 12 weeks.
Period Title: Overall Study
STARTED 155 156
Safety Population 152 155
COMPLETED 137 139
NOT COMPLETED 18 17

Baseline Characteristics

Arm/Group Title Placebo Relamorelin 10 μg Total
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks. Total of all reporting groups
Overall Participants 155 156 311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
54.1
(12.13)
55.8
(12.07)
55.0
(12.11)
Sex: Female, Male (Count of Participants)
Female
112
72.3%
114
73.1%
226
72.7%
Male
43
27.7%
42
26.9%
85
27.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
54
34.8%
51
32.7%
105
33.8%
Not Hispanic or Latino
101
65.2%
105
67.3%
206
66.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
4
2.6%
7
4.5%
11
3.5%
Asian
1
0.6%
2
1.3%
3
1%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
25
16.1%
17
10.9%
42
13.5%
White
123
79.4%
127
81.4%
250
80.4%
More than one race
2
1.3%
3
1.9%
5
1.6%
Unknown or Not Reported
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Description Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0= no or not at all uncomfortable to 10= worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period.
Time Frame Baseline (Day-14 to Day-1) to Week 12

Outcome Measure Data

Analysis Population Description
Modified Intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Baseline
23.4
(5.40)
24.9
(6.15)
Change from Baseline to Week 12
-9.3
(10.21)
-10.2
(9.24)
2. Primary Outcome
Title Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.
Time Frame Week 6 to Week 12

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Number [percentage of participants]
19.1
12.3%
18.7
12%
3. Secondary Outcome
Title Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no nausea to 10= worst possible nausea.
Time Frame Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Number [percentage of participants]
32.9
21.2%
38.1
24.4%
4. Secondary Outcome
Title Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0= no abdominal pain to 10= the worst possible abdominal pain and was recorded in an e-diary.
Time Frame Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Number [percentage of participants]
27.0
17.4%
36.1
23.1%
5. Secondary Outcome
Title Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no bloating and 10= the worst possible bloating and was recorded in the e-diary.
Time Frame Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Number [percentage of participants]
27.0
17.4%
31.6
20.3%
6. Secondary Outcome
Title Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0= no feeling of fullness until finishing a meal (best) to 10= feeling full after only a few bites (worst).
Time Frame Baseline (Day-14 to Day-1) to (Week 6 to Week 12)

Outcome Measure Data

Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Number [percentage of participants]
23.7
15.3%
27.7
17.8%
7. Secondary Outcome
Title Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Description An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Time Frame Up to approximately 16 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Count of Participants [Participants]
75
48.4%
86
55.1%
8. Secondary Outcome
Title Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time Frame Up to 12 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN)
0
0%
1
0.6%
Hematocrit (RATIO): >1.1×ULN
1
0.6%
0
0%
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)
4
2.6%
4
2.6%
Hemoglobin [grams (g)/L]: <0.9×LLN
2
1.3%
5
3.2%
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN
1
0.6%
3
1.9%
Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN
1
0.6%
1
0.6%
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN
0
0%
1
0.6%
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN
2
1.3%
2
1.3%
Red Blood Cell Count (10^12/L): <0.9×LLN
1
0.6%
1
0.6%
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN
1
0.6%
0
0%
Albumin (g/L): <0.9×LLN
0
0%
1
0.6%
Alkaline Phosphatase (U/L): >=3×ULN
1
0.6%
0
0%
Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN
1
0.6%
2
1.3%
Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN
0
0%
1
0.6%
Bicarbonate (HCO3) (mmol/L): <0.9×LLN
1
0.6%
0
0%
Blood Urea Nitrogen (mmol/L): >1.2×ULN
15
9.7%
3
1.9%
Chloride (mmol/L): <0.9×LLN
2
1.3%
0
0%
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN
2
1.3%
1
0.6%
Creatinine [micromoles(μmol)/L]: >1.3×ULN
8
5.2%
7
4.5%
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN
11
7.1%
21
13.5%
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN
6
3.9%
5
3.2%
Glycohemoglobin A1C: Increase of >=0.5%
80
51.6%
111
71.2%
Glycohemoglobin A1C: Increase of >=1%
80
51.6%
111
71.2%
Phosphorus (mmol/L): >1.1×ULN
5
3.2%
5
3.2%
Phosphorus (mmol/L): <0.9×LLN
1
0.6%
1
0.6%
Potassium (mmol/L): <0.9×LLN
1
0.6%
0
0%
Sodium (mmol/L): <0.9×LLN
1
0.6%
0
0%
Triglycerides, Fasting (mmol/L): >=3×ULN
3
1.9%
5
3.2%
Uric Acid (Urate) (μmol/L): >1.1×ULN
18
11.6%
13
8.3%
Uric Acid (Urate) (μmol/L): <0.9×LLN
3
1.9%
0
0%
9. Secondary Outcome
Title Number of Participants With Clinically Meaningful Trends for Vital Signs
Description Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Time Frame Up to 12 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Count of Participants [Participants]
0
0%
0
0%
10. Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Description A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame Up to 12 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 152 155
Count of Participants [Participants]
1
0.6%
2
1.3%
11. Secondary Outcome
Title Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Description
Time Frame Baseline (Day 1) up to 12 weeks

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment. Overall number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 146 151
Count of Participants [Participants]
80
51.6%
111
71.2%
12. Secondary Outcome
Title Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Description A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Time Frame Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=155 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed.
Arm/Group Title Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Measure Participants 155
Negative
127
81.9%
Positive
18
11.6%
Negative
12
7.7%
Positive
0
0%
Negative
115
74.2%
Positive
18
11.6%
Negative
13
8.4%
Positive
0
0%
Negative
104
67.1%
Positive
17
11%
Negative
12
7.7%
Positive
0
0%
Negative
87
56.1%
Positive
17
11%
Negative
11
7.1%
Positive
1
0.6%
Negative
6
3.9%
Positive
1
0.6%
Negative
1
0.6%
Positive
0
0%
Negative
6
3.9%
Positive
0
0%
Negative
Positive

Adverse Events

Time Frame Up to approximately 16 weeks
Adverse Event Reporting Description All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Arm/Group Title Placebo Relamorelin 10 μg
Arm/Group Description Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
All Cause Mortality
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/155 (0%) 0/156 (0%)
Serious Adverse Events
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/152 (3.9%) 8/155 (5.2%)
Cardiac disorders
Cardiac failure congestive 1/152 (0.7%) 1/155 (0.6%)
Gastrointestinal disorders
Abdominal pain 0/152 (0%) 1/155 (0.6%)
Diarrhoea 0/152 (0%) 1/155 (0.6%)
Nausea 0/152 (0%) 1/155 (0.6%)
Small intestinal obstruction 0/152 (0%) 1/155 (0.6%)
Vomiting 0/152 (0%) 1/155 (0.6%)
Infections and infestations
COVID-19 0/152 (0%) 1/155 (0.6%)
Pneumonia 0/152 (0%) 1/155 (0.6%)
Urinary tract infection 0/152 (0%) 1/155 (0.6%)
Influenza 1/152 (0.7%) 0/155 (0%)
Sepsis 1/152 (0.7%) 0/155 (0%)
Upper respiratory tract infection 1/152 (0.7%) 0/155 (0%)
Metabolism and nutrition disorders
Dehydration 1/152 (0.7%) 1/155 (0.6%)
Diabetic ketoacidosis 1/152 (0.7%) 1/155 (0.6%)
Malnutrition 1/152 (0.7%) 0/155 (0%)
Musculoskeletal and connective tissue disorders
Muscular weakness 1/152 (0.7%) 0/155 (0%)
Nervous system disorders
Headache 1/152 (0.7%) 0/155 (0%)
Renal and urinary disorders
Acute kidney injury 0/152 (0%) 1/155 (0.6%)
Renal failure 1/152 (0.7%) 0/155 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage 0/109 (0%) 1/113 (0.9%)
Respiratory, thoracic and mediastinal disorders
Asthma 1/152 (0.7%) 0/155 (0%)
Other (Not Including Serious) Adverse Events
Placebo Relamorelin 10 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 14/152 (9.2%) 13/155 (8.4%)
Gastrointestinal disorders
Diarrhoea 9/152 (5.9%) 5/155 (3.2%)
Infections and infestations
Urinary tract infection 5/152 (3.3%) 9/155 (5.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Therapeutic Area, Head
Organization Allergan
Phone 714-246-4500
Email clinicaltrials@allergan.com
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03426345
Other Study ID Numbers:
  • RLM-MD-02
  • 2017-002177-20
First Posted:
Feb 8, 2018
Last Update Posted:
Aug 6, 2021
Last Verified:
Jul 1, 2021