A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT03285308
Collaborator
(none)
336
216
2
33.3
1.6
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
:
336 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
:
Sep 29, 2017
Actual Primary Completion Date
:
Jul 8, 2020
Actual Study Completion Date
:
Jul 8, 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 μg injected subcutaneously twice daily for up to 12 weeks. |
Drug: Relamorelin
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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 results were clinically significant.
- 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.
- Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) [Baseline (Day 1) up to 12 weeks]
HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
- 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 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35295 |
| 2 | Digestive Health Specialist of the South East | Dothan | Alabama | United States | 36305 |
| 3 | Avant Research Associates | Huntsville | Alabama | United States | 35801 |
| 4 | Synexus Clinical Research US, Inc. | Fountain Hills | Arizona | United States | 85268 |
| 5 | Central Arizona Medical Associates | Mesa | Arizona | United States | 85206 |
| 6 | Phoenix Clinical LLC | Phoenix | Arizona | United States | 85014 |
| 7 | Del Sol Research Management, LLC | Tucson | Arizona | United States | 85712 |
| 8 | Preferred Research Partners, Inc. | Little Rock | Arkansas | United States | 72211 |
| 9 | Arkansas Gastorenterology | North Little Rock | Arkansas | United States | 72117 |
| 10 | Hope Clinical Research | Canoga Park | California | United States | 91303 |
| 11 | Kindred Medical Institute for Clinical Trials, LLC | Corona | California | United States | 92879 |
| 12 | Aurora Care Clinic, LLC | Costa Mesa | California | United States | 92627 |
| 13 | Citrus Valley Gastroenterology Clinic | Covina | California | United States | 91722 |
| 14 | VVCRD Research | Garden Grove | California | United States | 92845 |
| 15 | University of California San Diego | La Jolla | California | United States | 92037 |
| 16 | Om Research LLC | Lancaster | California | United States | 93534 |
| 17 | Clinical Applications Laboratories, Inc. | San Diego | California | United States | 92103 |
| 18 | Medical Associates Research Group, Inc | San Diego | California | United States | 92123 |
| 19 | Synexus Clinical Research, US, Santa Rosa | Santa Rosa | California | United States | 95405 |
| 20 | Upland Clinical Research | Upland | California | United States | 91786 |
| 21 | Synexus Clinical Research US, Inc. | Vista | California | United States | 92083 |
| 22 | University of Colorado, Denver | Aurora | Colorado | United States | 80045 |
| 23 | Peak Gastroenterology Associates | Colorado Springs | Colorado | United States | 80907 |
| 24 | Denver Esophageal and Stomach Center | Englewood | Colorado | United States | 80110 |
| 25 | Connecticut Clinical Research Foundation | Bristol | Connecticut | United States | 06010 |
| 26 | Medical Research Center of Connecticut, LLC | Hamden | Connecticut | United States | 06518 |
| 27 | TrialSpark, Inc. | Washington | District of Columbia | United States | 20017 |
| 28 | Innovative Research of West FL, Inc. | Clearwater | Florida | United States | 33756 |
| 29 | West Central Gastroenterology | Clearwater | Florida | United States | 33756 |
| 30 | American Research Institute, Inc | Cutler Bay | Florida | United States | 33157 |
| 31 | Top Medical Research | Cutler Bay | Florida | United States | 33189 |
| 32 | Nature Coast Clinical Research | Inverness | Florida | United States | 34452 |
| 33 | Cfagi Llc | Maitland | Florida | United States | 32751 |
| 34 | Savin Medical Group LLC | Miami Lakes | Florida | United States | 33014 |
| 35 | APF Research LLC | Miami | Florida | United States | 33134 |
| 36 | AMPM Research Clinic | Miami | Florida | United States | 33169 |
| 37 | Advanced Medical Research Institute | Miami | Florida | United States | 33174 |
| 38 | Florida Research Center, Inc. | Miami | Florida | United States | 33174 |
| 39 | Sensible Healthcare | Ocoee | Florida | United States | 34761 |
| 40 | Gulf Region Clinical Research Institute | Pensacola | Florida | United States | 32514 |
| 41 | University of South Florida | Tampa | Florida | United States | 33606 |
| 42 | West Central Gastroenterology | Tampa | Florida | United States | 33626 |
| 43 | Summit Clinical Research, LLC | Carnesville | Georgia | United States | 30521 |
| 44 | Infinite Clinical Trials | Riverdale | Georgia | United States | 30274 |
| 45 | Southwest Gastroenterology | Oak Lawn | Illinois | United States | 60453 |
| 46 | MediSphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
| 47 | Synexus Clinical Research US, Inc. | Evansville | Indiana | United States | 47714 |
| 48 | Indiana University Health University Hospital | Indianapolis | Indiana | United States | 46202 |
| 49 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 50 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 51 | Cotton-O'Neil Clinical Research Center - Digestive Health | Topeka | Kansas | United States | 66606 |
| 52 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 53 | Delta Research Partners | Bastrop | Louisiana | United States | 71220 |
| 54 | Cronola LLC | Houma | Louisiana | United States | 70360 |
| 55 | New Orleans Research Institute - Metropolitan Gastroenterology Associates | Metairie | Louisiana | United States | 70006 |
| 56 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
| 57 | Frederick Gastroenterology Associates, PA an Elligo Health Research Site | Frederick | Maryland | United States | 21701 |
| 58 | Boston VA Healthcare System | West Roxbury | Massachusetts | United States | 02132 |
| 59 | Vida Clinical Studies | Dearborn | Michigan | United States | 48124 |
| 60 | National Clinical, LLC | Hamtramck | Michigan | United States | 48212 |
| 61 | Henry Ford Health System | Novi | Michigan | United States | 48377 |
| 62 | Gastroenterology Associates of Western Michigan | Wyoming | Michigan | United States | 49519 |
| 63 | MNGI Digestive Health | Coon Rapids | Minnesota | United States | 55446 |
| 64 | Synexus Clinical Research US, Inc. | Richfield | Minnesota | United States | 55423 |
| 65 | Montana Medical Research | Missoula | Montana | United States | 59808 |
| 66 | Synexus Clinical Research | Henderson | Nevada | United States | 89052 |
| 67 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
| 68 | Clinical Research of South Nevada | Las Vegas | Nevada | United States | 89121 |
| 69 | Advanced Biomedical Research of America | Las Vegas | Nevada | United States | 89123 |
| 70 | Digestive Disease Specialists | Las Vegas | Nevada | United States | 89128 |
| 71 | Palm Research Center | Las Vegas | Nevada | United States | 89135 |
| 72 | Garden State Endocrinology | Brick | New Jersey | United States | 08723 |
| 73 | Synexus Clinical Research US, Inc. | Bridgeton | New Jersey | United States | 08302 |
| 74 | AGA Clinical Research Associates LLC | Egg Harbor Township | New Jersey | United States | 08234 |
| 75 | CHEAR Center, LLC | Bronx | New York | United States | 10455 |
| 76 | Long Island Gastrointestinal Research Group LLP | Great Neck | New York | United States | 11023 |
| 77 | United Health Services Hospitals, Inc. | Johnson City | New York | United States | 13790 |
| 78 | Asheville Gastroenterology Associates | Asheville | North Carolina | United States | 28801 |
| 79 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7080 |
| 80 | Carolinas Healthcare-Charlotte | Charlotte | North Carolina | United States | 28204 |
| 81 | Carolina Digestive Health Associates | Concord | North Carolina | United States | 28025 |
| 82 | Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States | 28304 |
| 83 | Triad Clinical Trials | Greensboro | North Carolina | United States | 27410 |
| 84 | PMG Research Salisbury | Salisbury | North Carolina | United States | 28144 |
| 85 | The Center for Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
| 86 | Dayton Gastroenterology,Inc. | Beavercreek | Ohio | United States | 45440 |
| 87 | Endocrinology Research Associates, Inc. | Columbus | Ohio | United States | 43201 |
| 88 | Hometown Urgent Care and Research | Columbus | Ohio | United States | 43214 |
| 89 | Premier Clinical Research d.b.a. STAT Research | Franklin | Ohio | United States | 45005 |
| 90 | Family Practice Center of Wadsworth, Inc. | Wadsworth | Ohio | United States | 44281 |
| 91 | Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | United States | 73112 |
| 92 | Memorial Clinical Research | Oklahoma City | Oklahoma | United States | 73120 |
| 93 | Northwest Gastroenterology Clinic, LLC | Portland | Oregon | United States | 97210 |
| 94 | Family Medical Associates, Research Department | Levittown | Pennsylvania | United States | 19056 |
| 95 | Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | United States | 15236 |
| 96 | Montgomery Medical, Inc. | Smithfield | Pennsylvania | United States | 15478 |
| 97 | Synexus Clinical Research US, Inc. | Anderson | South Carolina | United States | 29621 |
| 98 | Carolina Medical Research | Clinton | South Carolina | United States | 29325 |
| 99 | Gastroenterology Associates, PA | Greenville | South Carolina | United States | 29615 |
| 100 | Synexus Clinical Research | Greer | South Carolina | United States | 29650 |
| 101 | Quality Medical Research | Nashville | Tennessee | United States | 37211 |
| 102 | Avant Research Associates,LLC | Austin | Texas | United States | 78704 |
| 103 | Synexus Clinical Research US, Inc. | Dallas | Texas | United States | 75234 |
| 104 | Amir Ali Hassan, MD, PA | Houston | Texas | United States | 77089 |
| 105 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 106 | Sagact Pllc | San Antonio | Texas | United States | 78229 |
| 107 | Synexus Clinical Research US, Inc. | Layton | Utah | United States | 84041 |
| 108 | Synexus Clinical Research US, Inc. | Murray | Utah | United States | 84123 |
| 109 | Advanced Research Institute, Inc. | Ogden | Utah | United States | 84405 |
| 110 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
| 111 | Verity Research Inc. | Fairfax | Virginia | United States | 22031 |
| 112 | Cardinal Internal Medicine | Woodbridge | Virginia | United States | 22192 |
| 113 | West Virginia University | Morgantown | West Virginia | United States | 26506 |
| 114 | Nepean Hospital | Kingswood | New South Wales | Australia | 2747 |
| 115 | Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated | Adelaide | South Australia | Australia | 5000 |
| 116 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 117 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 118 | MHAT Yuliya Vrevska Byala | Byala | Ruse | Bulgaria | 7100 |
| 119 | UMHAT - Kaspela- EOOD | Plovdiv | Bulgaria | 4001 | |
| 120 | Medical Center Asklepion - Humane Medicine Research EOOD | Sofia | Bulgaria | 1303 | |
| 121 | Alexandrovska University Hospital | Sofia | Bulgaria | 1431 | |
| 122 | CHU Nantes | Nantes Cedex 1 | France | 44093 | |
| 123 | Hopital Charles Nicolle | Rouen Cedex | France | 76031 | |
| 124 | Kumudini Devi Diabetes Research Center; Ramdevrao Hospital | Hyderabad | Andhra Pradesh | India | 500072 |
| 125 | King George Hospital | Visakhapatnam | Andhra Pradesh | India | 530002 |
| 126 | Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology | Ahmedabad | Gujarat | India | 380007 |
| 127 | Victoria Hospital | Bangalore | Karnataka | India | 560002 |
| 128 | Life Care Hospital & Research Centre | Bangalore | Karnataka | India | 560092 |
| 129 | Diacon Hospital and research Center - Diabetology | Bengaluru | Karnataka | India | 359-360 |
| 130 | Rajalakshmi Hospital | Bengaluru | Karnataka | India | 560097 |
| 131 | Vinaya Hospital & Research Centre | Mangalore | Karnataka | India | 575003 |
| 132 | Bhatia Hospital | Mumbai | Maharashtra | India | 400007 |
| 133 | B. J. Government Medical College and Sassoon General Hospitals | Pune | Maharashtra | India | 411001 |
| 134 | Universal Hospital | Pune | Maharashtra | India | 411011 |
| 135 | Noble Hospital Pvt. Ltd | Pune | Maharashtra | India | 411013 |
| 136 | S R Kalla (SRK) Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
| 137 | SMS Hospital | Jaipur | Rajasthan | India | 302004 |
| 138 | Diabetic Thyroid and Endocrine Centre | Jaipur | Rajasthan | India | 302006 |
| 139 | Marudhar Hospital | Jaipur | Rajasthan | India | 302012 |
| 140 | Eternal Hospital - Diabetology | Jaipur | Rajasthan | India | 302017 |
| 141 | M.V. Hospital for Diabetes & Diabetes Research Centre | Chennai | Tamil Nadu | India | 600013 |
| 142 | Kovai Diabetes Speciality Centre | Coimbatore | Tamil Nadu | India | 641009 |
| 143 | M V Hospital & Research Centre | Lucknow | Uttar Pradesh | India | 226003 |
| 144 | Arthur Asirvatham Hospital | Madurai | India | 625020 | |
| 145 | Sir Ganga Ram Hospital | New Delhi | India | 110060 | |
| 146 | Soroka University Medical Center | Beer Sheba | Israel | 85025 | |
| 147 | Bnai Zion Medical Center | Haifa | Israel | 31048 | |
| 148 | E. Wolfson Medical Center | Holon | Israel | 58100 | |
| 149 | Digestive Diseases Institute | Jerusalem | Israel | 9103102 | |
| 150 | Gastroenterology Institute | Petach Tikva | Israel | 49100 | |
| 151 | Endocrinology & Diabetes Center | Safed | Israel | 13100 | |
| 152 | Gastroenterology Institute | Tel Aviv | Israel | 64239 | |
| 153 | Chonbuk National University Hospital | Jeonju | Jeollabuk-Do | Korea, Republic of | 561-712 |
| 154 | Sanggye Paik Hospital, Inje University College of Medicine | Seoul | Nowon-gu | Korea, Republic of | 01757 |
| 155 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 156 | Hospital Sultanah Bahiyah | Alor Setar | Kedah | Malaysia | 5460 |
| 157 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 158 | Universiti Sains Malaysia | Kubang Kerian | Malaysia | 16150 | |
| 159 | Hospital Taiping | Taiping | Malaysia | 34000 | |
| 160 | Manila Doctors Hospital | Ermita | Manila | Philippines | 1000 |
| 161 | San Juan De Dios Educational Foundation, Inc. | Pasay | Metro Manila | Philippines | 1300 |
| 162 | Cardinal Santos Medical Center | San Juan City | Metro Manila | Philippines | 1502 |
| 163 | Ospital ng Makati | Makati City | NCR | Philippines | 1218 |
| 164 | Perpetual Succor Hospital | Cebu City | Philippines | 6000 | |
| 165 | West Visayas State University Medical Center | IloIlo City | Philippines | 5000 | |
| 166 | St. Luke's Medical Center | Quezon City | Philippines | 1100 | |
| 167 | Synexus Polska Sp.z o.o. | Pomorskie | Gdansk | Poland | 80-382 |
| 168 | CenterMed Krakow Ltd | Krakow | Malopolska | Poland | 31-530 |
| 169 | Centrum Medyczne Pratia S.A. Warsaw, Poland | Warsaw | Mazowian | Poland | 01-868 |
| 170 | Endoskopia Sp. Z O.O. | Sopot | Pomorskie | Poland | 81-756 |
| 171 | Synexus Polska Sp. z o.o.Oddzial w Poznaniu | Poznan | Poznañ | Poland | 60-702 |
| 172 | Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | Warmia-Mazury | Poland | 10-561 |
| 173 | NZOZ Vita Diabetica - Malgorzata Buraczyk | Bialystok | Poland | 15-798 | |
| 174 | Centrum Medyczne Lukamed | Chojnice | Poland | 89-600 | |
| 175 | Synexus Polska sp.z.o.o oddzial Czestochowa | Czestochowa | Poland | 42-202 | |
| 176 | Specjalistyczny Gabinet Neurologiczny Marta Banach | Kraków | Poland | 30-539 | |
| 177 | Synexus Polska Sp. z o.o. Oddzial w Lodzi | Lodz | Poland | 90-127 | |
| 178 | Sanitas Centrum Medyczne | Lublin | Poland | 20-090 | |
| 179 | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | Poland | ||
| 180 | DRS Wroclaw | Wroclaw | Poland | 50-381 | |
| 181 | Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland | 51-162 | |
| 182 | National University Hospital | Singapore | Singapore | 119228 | |
| 183 | Changi General Hospital | Singapore | Singapore | 529889 | |
| 184 | Singapore General Hospital | Singapore | Singapore | S169856 | |
| 185 | Hospital Universitario Principe de Asturias | Madrid | Spain | 28850 | |
| 186 | Hospital Universitario De Salamanca | Salamanca | Spain | 37007 | |
| 187 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | 41009 | |
| 188 | Phramongkutklao Hospital | Bangkok | Thailand | 10400 | |
| 189 | Faculty of Medicine, Siriraj Hospital, Mahidol University | Bangkok | Thailand | 10700 | |
| 190 | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand | 50200 | |
| 191 | Communal Institution "Odesa Regional Clinical Hospital", Out-patient department | Odesa | Odesa Region | Ukraine | 65025 |
| 192 | Limited Liability Company "Medical Center "Salutem" | Vinnitsa | Vinnyts'ka Oblast' | Ukraine | 21050 |
| 193 | Municipal Institution City Hospital No. 7 | Zaporizhzhia | Zaporizhzhia Region | Ukraine | 69600 |
| 194 | Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C | Chernivtsi | Ukraine | 58001 | |
| 195 | Regional Public Organization Chernivtsi Regional Endocrinology Center | Chernivtsi | Ukraine | 58022 | |
| 196 | State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine | Dnipro | Ukraine | 49027 | |
| 197 | Ivano-Frankivsk National Medical University | Ivano-Frankivsk | Ukraine | 76008 | |
| 198 | Ivano-Frankivsk Central City Clinical Hospital | Ivano-Frankivsk | Ukraine | 76018 | |
| 199 | Municipal nonprofit entity of Kharkiv municipal council | Kharkiv | Ukraine | 61037 | |
| 200 | L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine | Kharkiv | Ukraine | 61039 | |
| 201 | Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine" | Kharkiv | Ukraine | 61070 | |
| 202 | Communal Institution Kherson City Clinical Hospital | Kherson | Ukraine | 73000 | |
| 203 | Kyiv municipal clinical endocrinological center | Kyiv | Ukraine | 01034 | |
| 204 | AS Medbud Clinic | Kyiv | Ukraine | 03037 | |
| 205 | AS PVNZ | Kyiv | Ukraine | 2002 | |
| 206 | Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv | Kyiv | Ukraine | 2002 | |
| 207 | Kyiv Railway hospital on the railway transport #2 of the branch "health | Kyiv | Ukraine | 3049 | |
| 208 | Medical Center Universal Clinic Oberig | Kyiv | Ukraine | 3680 | |
| 209 | Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit | Kyiv | Ukraine | 4050 | |
| 210 | Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University | Odesa | Ukraine | 65010 | |
| 211 | Poltava Regional Clinical Hospital | Poltava | Ukraine | 36011 | |
| 212 | Ternopil University Hospital | Ternopil | Ukraine | 46002 | |
| 213 | Private Small-Scale Enterprise Medical Centre Pulse | Vinnytsia | Ukraine | 21001 | |
| 214 | Vinnytsia Regional Clinical highly specialized Endocrinology Centre | Vinnytsia | Ukraine | 21010 | |
| 215 | Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia | Vinnytsia | Ukraine | 21029 | |
| 216 | 6th City Clinical Hospital, c. Zaporizhzhia | Zaporizhzhia | Ukraine | 69035 |
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:
NCT03285308
Other Study ID Numbers:
- RLM-MD-01
- 2017-002136-16
First Posted:
Sep 18, 2017
Last Update Posted:
Jul 29, 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 μg injected subcutaneously twice daily for up to 12 weeks. |
| Period Title: Overall Study | ||
| STARTED | 167 | 169 |
| Safety Population | 163 | 163 |
| COMPLETED | 147 | 146 |
| NOT COMPLETED | 20 | 23 |
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 | 167 | 169 | 336 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55.4
(10.78)
|
56.3
(11.47)
|
55.9
(11.13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
107
64.1%
|
115
68%
|
222
66.1%
|
| Male |
60
35.9%
|
54
32%
|
114
33.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
51
30.5%
|
53
31.4%
|
104
31%
|
| Not Hispanic or Latino |
116
69.5%
|
116
68.6%
|
232
69%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.6%
|
1
0.3%
|
| Asian |
26
15.6%
|
24
14.2%
|
50
14.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
25
15%
|
19
11.2%
|
44
13.1%
|
| White |
116
69.5%
|
125
74%
|
241
71.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| 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. Number analyzed is the number of participants with data available at the given time-point. |
| 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 | 163 | 165 |
| Baseline |
25.1
(5.53)
|
24.5
(5.99)
|
| Change from Baseline to Week 12 |
-10.0
(8.89)
|
-9.3
(8.17)
|
| 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 | 164 | 165 |
| Number [percentage of participants] |
19.5
11.7%
|
21.8
12.9%
|
| 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 | 164 | 165 |
| Number [percentage of participants] |
34.1
20.4%
|
29.7
17.6%
|
| 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 | 164 | 165 |
| Number [percentage of participants] |
28.0
16.8%
|
27.9
16.5%
|
| 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 | 164 | 165 |
| Number [percentage of participants] |
26.2
15.7%
|
27.9
16.5%
|
| 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 | 164 | 165 |
| Number [percentage of participants] |
22.6
13.5%
|
25.5
15.1%
|
| 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 | 163 | 163 |
| Count of Participants [Participants] |
68
40.7%
|
70
41.4%
|
| 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 | 163 | 163 |
| Eosinophils Absolute Cell Count [10^9/liter(L)]: >3×Upper Limit of Normal Value (ULN) |
0
0%
|
1
0.6%
|
| Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) |
2
1.2%
|
2
1.2%
|
| Hemoglobin (g/L): <0.9×LLN |
10
6%
|
4
2.4%
|
| Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN |
1
0.6%
|
0
0%
|
| Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN |
2
1.2%
|
1
0.6%
|
| Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN |
2
1.2%
|
0
0%
|
| 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
1.2%
|
3
1.8%
|
| Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN |
0
0%
|
1
0.6%
|
| Red Blood Cell Count (10^12/L): >1.1×ULN |
0
0%
|
1
0.6%
|
| Red Blood Cell Count (10^12/L): <0.9×LLN |
1
0.6%
|
1
0.6%
|
| White Blood Cell Count (10^9/L): >1.5×ULN |
1
0.6%
|
1
0.6%
|
| Bicarbonate (HCO3) (mmol/L): >1.1×ULN |
3
1.8%
|
1
0.6%
|
| Bicarbonate (HCO3) (mmol/L): >0.9×LLN |
3
1.8%
|
1
0.6%
|
| Blood Urea Nitrogen [millimoles(mmol/L)]: >1.2×ULN |
11
6.6%
|
11
6.5%
|
| Calcium (mmol/L): <0.9×LLN |
0
0%
|
1
0.6%
|
| Cholesterol, Total, Non-Fasting (mmol/L) |
0
0%
|
1
0.6%
|
| Creatinine [micromoles(μmol/L)]: >1.3×ULN |
7
4.2%
|
8
4.7%
|
| Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN |
10
6%
|
21
12.4%
|
| Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN |
3
1.8%
|
1
0.6%
|
| Glycohemoglobin A1C: Increase of >=0.5% |
91
54.5%
|
125
74%
|
| Glycohemoglobin A1C: Increase of >=1% |
91
54.5%
|
124
73.4%
|
| Phosphorus (mmol/L): >1.1×ULN |
2
1.2%
|
5
3%
|
| Phosphorus (mmol/L): <0.9×LLN |
0
0%
|
1
0.6%
|
| Triglycerides, Fasting (mmol/L): >=3×ULN |
5
3%
|
5
3%
|
| Uric Acid (Urate) (μmol/L): >1.1×ULN |
10
6%
|
18
10.7%
|
| Uric Acid (Urate) (μmol/L): <0.9×LLN |
1
0.6%
|
3
1.8%
|
| 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 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 | 163 | 163 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| 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 | 163 | 163 |
| Count of Participants [Participants] |
4
2.4%
|
3
1.8%
|
| Title | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) |
|---|---|
| Description | HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound. |
| 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. 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 | 163 | 163 |
| Glycohemoglobin A1C: Increase of >=0.5% |
91
54.5%
|
125
74%
|
| Glycohemoglobin A1C: Increase of >=1% |
91
54.5%
|
124
73.4%
|
| 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=163 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 | 163 |
| Negative |
133
79.6%
|
| Positive |
16
9.6%
|
| Negative |
13
7.8%
|
| Positive |
2
1.2%
|
| Negative |
124
74.3%
|
| Positive |
13
7.8%
|
| Negative |
13
7.8%
|
| Positive |
0
0%
|
| Negative |
115
68.9%
|
| Positive |
16
9.6%
|
| Negative |
15
9%
|
| Positive |
1
0.6%
|
| Negative |
95
56.9%
|
| Positive |
16
9.6%
|
| Negative |
14
8.4%
|
| Positive |
1
0.6%
|
| Negative |
13
7.8%
|
| Positive |
2
1.2%
|
| Negative |
2
1.2%
|
| Positive |
0
0%
|
| Negative |
2
1.2%
|
| Positive |
2
1.2%
|
| Negative |
1
0.6%
|
| Positive |
1
0.6%
|
Adverse Events
| Time Frame | Up to approximately 16 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All-Cause Mortality is based on the Intent-to-treat (ITT) Population. 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 | 0/167 (0%) | 0/169 (0%) | ||
Serious Adverse Events |
||||
| Placebo | Relamorelin 10 μg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/163 (9.2%) | 16/163 (9.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/163 (0%) | 1/163 (0.6%) | ||
| Leukopenia | 1/163 (0.6%) | 0/163 (0%) | ||
| Thrombocytopenia | 1/163 (0.6%) | 0/163 (0%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 1/163 (0.6%) | 1/163 (0.6%) | ||
| Angina unstable | 0/163 (0%) | 1/163 (0.6%) | ||
| Atrial fibrillation | 1/163 (0.6%) | 0/163 (0%) | ||
| Cardiac failure congestive | 1/163 (0.6%) | 0/163 (0%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 1/163 (0.6%) | 1/163 (0.6%) | ||
| Colitis | 0/163 (0%) | 1/163 (0.6%) | ||
| Constipation | 0/163 (0%) | 1/163 (0.6%) | ||
| Gastrointestinal haemorrhage | 0/163 (0%) | 1/163 (0.6%) | ||
| Impaired gastric emptying | 0/163 (0%) | 1/163 (0.6%) | ||
| Diabetic gastroparesis | 1/163 (0.6%) | 0/163 (0%) | ||
| Pancreatitis | 1/163 (0.6%) | 0/163 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 3/163 (1.8%) | 2/163 (1.2%) | ||
| Diverticulitis | 0/163 (0%) | 2/163 (1.2%) | ||
| Urinary tract infection | 2/163 (1.2%) | 1/163 (0.6%) | ||
| Acute sinusitis | 0/163 (0%) | 1/163 (0.6%) | ||
| Sepsis | 2/163 (1.2%) | 0/163 (0%) | ||
| Cystitis | 1/163 (0.6%) | 0/163 (0%) | ||
| Pyelonephritis acute | 1/163 (0.6%) | 0/163 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 2/163 (1.2%) | 2/163 (1.2%) | ||
| Thoracic vertebral fracture | 0/163 (0%) | 1/163 (0.6%) | ||
| Ankle fracture | 1/163 (0.6%) | 0/163 (0%) | ||
| Tibia fracture | 1/163 (0.6%) | 0/163 (0%) | ||
| Investigations | ||||
| Anticoagulation drug level above therapeutic | 1/163 (0.6%) | 0/163 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 0/163 (0%) | 1/163 (0.6%) | ||
| Dehydration | 1/163 (0.6%) | 0/163 (0%) | ||
| Diabetes mellitus | 1/163 (0.6%) | 0/163 (0%) | ||
| Hyperglycaemia | 1/163 (0.6%) | 0/163 (0%) | ||
| Hyperglycaemic hyperosmolar nonketotic syndrome | 1/163 (0.6%) | 0/163 (0%) | ||
| Hypomagnesaemia | 1/163 (0.6%) | 0/163 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/163 (0%) | 1/163 (0.6%) | ||
| Cervical spinal stenosis | 1/163 (0.6%) | 0/163 (0%) | ||
| Vertebral wedging | 1/163 (0.6%) | 0/163 (0%) | ||
| Nervous system disorders | ||||
| Syncope | 0/163 (0%) | 1/163 (0.6%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 2/163 (1.2%) | 1/163 (0.6%) | ||
| Diabetic nephropathy | 1/163 (0.6%) | 0/163 (0%) | ||
| Hydronephrosis | 1/163 (0.6%) | 0/163 (0%) | ||
| Nephrolithiasis | 1/163 (0.6%) | 0/163 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 2/163 (1.2%) | 0/163 (0%) | ||
| Asthma | 1/163 (0.6%) | 0/163 (0%) | ||
| Hypercapnia | 1/163 (0.6%) | 0/163 (0%) | ||
| Pulmonary embolism | 1/163 (0.6%) | 0/163 (0%) | ||
| Pulmonary oedema | 1/163 (0.6%) | 0/163 (0%) | ||
| Respiratory failure | 1/163 (0.6%) | 0/163 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 1/163 (0.6%) | 1/163 (0.6%) | ||
| Hypovolaemic shock | 1/163 (0.6%) | 0/163 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Relamorelin 10 μg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/163 (5.5%) | 9/163 (5.5%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | 9/163 (5.5%) | 9/163 (5.5%) | ||
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 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03285308
Other Study ID Numbers:
- RLM-MD-01
- 2017-002136-16
First Posted:
Sep 18, 2017
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021