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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285308
Recruitment Status : Terminated (The Relamorelin program is being terminated solely based on a business decision.)
First Posted : September 18, 2017
Results First Posted : July 29, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Gastroparesis
Diabetes Mellitus
Interventions Drug: Placebo
Drug: Relamorelin
Enrollment 336
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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 [1] 163 163
Completed 147 146
Not Completed 20 23
Reason Not Completed
Adverse Event             3             7
Withdrawal by Subject             8             9
Lost to Follow-up             3             1
Protocol Deviation             6             5
Reason not Specified             0             1
[1]
Safety Population included participants who received ≥1 administration of Double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg Total
Hide 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 Number of Baseline Participants 167 169 336
Hide Baseline Analysis Population Description
ITT Population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 169 participants 336 participants
55.4  (10.78) 56.3  (11.47) 55.9  (11.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 169 participants 336 participants
Female
107
  64.1%
115
  68.0%
222
  66.1%
Male
60
  35.9%
54
  32.0%
114
  33.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 169 participants 336 participants
Hispanic or Latino
51
  30.5%
53
  31.4%
104
  31.0%
Not Hispanic or Latino
116
  69.5%
116
  68.6%
232
  69.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 169 participants 336 participants
American Indian or Alaska Native
0
   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%
0
   0.0%
Black or African American
25
  15.0%
19
  11.2%
44
  13.1%
White
116
  69.5%
125
  74.0%
241
  71.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 163 165
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 163 participants 165 participants
25.1  (5.53) 24.5  (5.99)
Change from Baseline to Week 12 Number Analyzed 142 participants 141 participants
-10.0  (8.89) -9.3  (8.17)
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: percentage of participants
19.5 21.8
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: percentage of participants
34.1 29.7
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: percentage of participants
28.0 27.9
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: percentage of participants
26.2 27.9
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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 164 165
Measure Type: Number
Unit of Measure: percentage of participants
22.6 25.5
7.Secondary Outcome
Title Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
68
  41.7%
70
  42.9%
8.Secondary Outcome
Title Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
Eosinophils Absolute Cell Count [10^9/liter(L)]: >3×Upper Limit of Normal Value (ULN) Number Analyzed 152 participants 158 participants
0
   0.0%
1
   0.6%
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) Number Analyzed 145 participants 157 participants
2
   1.4%
2
   1.3%
Hemoglobin (g/L): <0.9×LLN Number Analyzed 147 participants 153 participants
10
   6.8%
4
   2.6%
Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN Number Analyzed 151 participants 158 participants
1
   0.7%
0
   0.0%
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN Number Analyzed 151 participants 158 participants
2
   1.3%
1
   0.6%
Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN Number Analyzed 151 participants 158 participants
2
   1.3%
0
   0.0%
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN Number Analyzed 150 participants 156 participants
0
   0.0%
1
   0.6%
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN Number Analyzed 150 participants 156 participants
2
   1.3%
3
   1.9%
Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN Number Analyzed 152 participants 158 participants
0
   0.0%
1
   0.6%
Red Blood Cell Count (10^12/L): >1.1×ULN Number Analyzed 151 participants 159 participants
0
   0.0%
1
   0.6%
Red Blood Cell Count (10^12/L): <0.9×LLN Number Analyzed 151 participants 159 participants
1
   0.7%
1
   0.6%
White Blood Cell Count (10^9/L): >1.5×ULN Number Analyzed 152 participants 159 participants
1
   0.7%
1
   0.6%
Bicarbonate (HCO3) (mmol/L): >1.1×ULN Number Analyzed 152 participants 156 participants
3
   2.0%
1
   0.6%
Bicarbonate (HCO3) (mmol/L): >0.9×LLN Number Analyzed 152 participants 156 participants
3
   2.0%
1
   0.6%
Blood Urea Nitrogen [millimoles(mmol/L)]: >1.2×ULN Number Analyzed 137 participants 153 participants
11
   8.0%
11
   7.2%
Calcium (mmol/L): <0.9×LLN Number Analyzed 153 participants 160 participants
0
   0.0%
1
   0.6%
Cholesterol, Total, Non-Fasting (mmol/L) Number Analyzed 151 participants 158 participants
0
   0.0%
1
   0.6%
Creatinine [micromoles(μmol/L)]: >1.3×ULN Number Analyzed 141 participants 149 participants
7
   5.0%
8
   5.4%
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN Number Analyzed 141 participants 148 participants
10
   7.1%
21
  14.2%
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN Number Analyzed 141 participants 148 participants
3
   2.1%
1
   0.7%
Glycohemoglobin A1C: Increase of >=0.5% Number Analyzed 155 participants 160 participants
91
  58.7%
125
  78.1%
Glycohemoglobin A1C: Increase of >=1% Number Analyzed 155 participants 160 participants
91
  58.7%
124
  77.5%
Phosphorus (mmol/L): >1.1×ULN Number Analyzed 147 participants 156 participants
2
   1.4%
5
   3.2%
Phosphorus (mmol/L): <0.9×LLN Number Analyzed 147 participants 156 participants
0
   0.0%
1
   0.6%
Triglycerides, Fasting (mmol/L): >=3×ULN Number Analyzed 149 participants 154 participants
5
   3.4%
5
   3.2%
Uric Acid (Urate) (μmol/L): >1.1×ULN Number Analyzed 123 participants 130 participants
10
   8.1%
18
  13.8%
Uric Acid (Urate) (μmol/L): <0.9×LLN Number Analyzed 123 participants 130 participants
1
   0.8%
3
   2.3%
9.Secondary Outcome
Title Number of Participants With Clinically Meaningful Trends for Vital Signs
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Hide Description A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who received ≥1 administration of double-blind study treatment.
Arm/Group Title Placebo Relamorelin 10 μg
Hide 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.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.5%
3
   1.8%
11.Secondary Outcome
Title Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 163 163
Measure Type: Count of Participants
Unit of Measure: Participants
Glycohemoglobin A1C: Increase of >=0.5% Number Analyzed 155 participants 160 participants
91
  58.7%
125
  78.1%
Glycohemoglobin A1C: Increase of >=1% Number Analyzed 155 participants 160 participants
91
  58.7%
124
  77.5%
12.Secondary Outcome
Title Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Overall Number of Participants Analyzed 163
Measure Type: Count of Participants
Unit of Measure: Participants
Screening Test (Baseline) Number Analyzed 149 participants
Negative
133
  89.3%
Positive
16
  10.7%
Confirmatory Test (Baseline) Number Analyzed 15 participants
Negative
13
  86.7%
Positive
2
  13.3%
Screening Test (Day 14) Number Analyzed 137 participants
Negative
124
  90.5%
Positive
13
   9.5%
Confirmatory Test (Day 14) Number Analyzed 13 participants
Negative
13
 100.0%
Positive
0
   0.0%
Screening Test (Day 28) Number Analyzed 131 participants
Negative
115
  87.8%
Positive
16
  12.2%
Confirmatory Test (Day 28) Number Analyzed 16 participants
Negative
15
  93.8%
Positive
1
   6.3%
Screening Test (Day 84) Number Analyzed 111 participants
Negative
95
  85.6%
Positive
16
  14.4%
Confirmatory Test (Day 84) Number Analyzed 15 participants
Negative
14
  93.3%
Positive
1
   6.7%
Screening Test (End of Treatment) Number Analyzed 15 participants
Negative
13
  86.7%
Positive
2
  13.3%
Confirmatory Test (End of Treatment) Number Analyzed 2 participants
Negative
2
 100.0%
Positive
0
   0.0%
Screening Test (Unscheduled) Number Analyzed 4 participants
Negative
2
  50.0%
Positive
2
  50.0%
Confirmatory Test (Unscheduled) Number Analyzed 2 participants
Negative
1
  50.0%
Positive
1
  50.0%
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
Hide 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 (%) Affected / at Risk (%)
Total   0/167 (0.00%)   0/169 (0.00%) 
Hide Serious Adverse Events
Placebo Relamorelin 10 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   15/163 (9.20%)   16/163 (9.82%) 
Blood and lymphatic system disorders     
Anaemia  1  0/163 (0.00%)  1/163 (0.61%) 
Leukopenia  1  1/163 (0.61%)  0/163 (0.00%) 
Thrombocytopenia  1  1/163 (0.61%)  0/163 (0.00%) 
Cardiac disorders     
Angina pectoris  1  1/163 (0.61%)  1/163 (0.61%) 
Angina unstable  1  0/163 (0.00%)  1/163 (0.61%) 
Atrial fibrillation  1  1/163 (0.61%)  0/163 (0.00%) 
Cardiac failure congestive  1  1/163 (0.61%)  0/163 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  1/163 (0.61%)  1/163 (0.61%) 
Colitis  1  0/163 (0.00%)  1/163 (0.61%) 
Constipation  1  0/163 (0.00%)  1/163 (0.61%) 
Gastrointestinal haemorrhage  1  0/163 (0.00%)  1/163 (0.61%) 
Impaired gastric emptying  1  0/163 (0.00%)  1/163 (0.61%) 
Diabetic gastroparesis  1  1/163 (0.61%)  0/163 (0.00%) 
Pancreatitis  1  1/163 (0.61%)  0/163 (0.00%) 
Infections and infestations     
Pneumonia  1  3/163 (1.84%)  2/163 (1.23%) 
Diverticulitis  1  0/163 (0.00%)  2/163 (1.23%) 
Urinary tract infection  1  2/163 (1.23%)  1/163 (0.61%) 
Acute sinusitis  1  0/163 (0.00%)  1/163 (0.61%) 
Sepsis  1  2/163 (1.23%)  0/163 (0.00%) 
Cystitis  1  1/163 (0.61%)  0/163 (0.00%) 
Pyelonephritis acute  1  1/163 (0.61%)  0/163 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  2/163 (1.23%)  2/163 (1.23%) 
Thoracic vertebral fracture  1  0/163 (0.00%)  1/163 (0.61%) 
Ankle fracture  1  1/163 (0.61%)  0/163 (0.00%) 
Tibia fracture  1  1/163 (0.61%)  0/163 (0.00%) 
Investigations     
Anticoagulation drug level above therapeutic  1  1/163 (0.61%)  0/163 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/163 (0.00%)  1/163 (0.61%) 
Dehydration  1  1/163 (0.61%)  0/163 (0.00%) 
Diabetes mellitus  1  1/163 (0.61%)  0/163 (0.00%) 
Hyperglycaemia  1  1/163 (0.61%)  0/163 (0.00%) 
Hyperglycaemic hyperosmolar nonketotic syndrome  1  1/163 (0.61%)  0/163 (0.00%) 
Hypomagnesaemia  1  1/163 (0.61%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/163 (0.00%)  1/163 (0.61%) 
Cervical spinal stenosis  1  1/163 (0.61%)  0/163 (0.00%) 
Vertebral wedging  1  1/163 (0.61%)  0/163 (0.00%) 
Nervous system disorders     
Syncope  1  0/163 (0.00%)  1/163 (0.61%) 
Renal and urinary disorders     
Acute kidney injury  1  2/163 (1.23%)  1/163 (0.61%) 
Diabetic nephropathy  1  1/163 (0.61%)  0/163 (0.00%) 
Hydronephrosis  1  1/163 (0.61%)  0/163 (0.00%) 
Nephrolithiasis  1  1/163 (0.61%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/163 (1.23%)  0/163 (0.00%) 
Asthma  1  1/163 (0.61%)  0/163 (0.00%) 
Hypercapnia  1  1/163 (0.61%)  0/163 (0.00%) 
Pulmonary embolism  1  1/163 (0.61%)  0/163 (0.00%) 
Pulmonary oedema  1  1/163 (0.61%)  0/163 (0.00%) 
Respiratory failure  1  1/163 (0.61%)  0/163 (0.00%) 
Vascular disorders     
Hypertension  1  1/163 (0.61%)  1/163 (0.61%) 
Hypovolaemic shock  1  1/163 (0.61%)  0/163 (0.00%) 
1
Term from vocabulary, MedDRA: 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Relamorelin 10 μg
Affected / at Risk (%) Affected / at Risk (%)
Total   9/163 (5.52%)   9/163 (5.52%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  9/163 (5.52%)  9/163 (5.52%) 
1
Term from vocabulary, MedDRA: 23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03285308    
Other Study ID Numbers: RLM-MD-01
2017-002136-16 ( EudraCT Number )
First Submitted: September 14, 2017
First Posted: September 18, 2017
Results First Submitted: July 8, 2021
Results First Posted: July 29, 2021
Last Update Posted: July 29, 2021