Trial · NCT02357420

Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

NCT02357420, Phase 2, Completed, Allergan; results first posted 2019-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis. Trials, record NCT02357420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02357420

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
NCT number: NCT02357420
Status: Completed
Phases: Phase 2
Enrollment: 393 participants, actual
Lead sponsor: Allergan
Conditions: Diabetes Mellitus, Diabetes Mellitus Complications, Gastroparesis
Interventions: Relamorelin, Placebo
First posted: 2015-02-06
Last updated: 2019-07-24
Other registries' IDs: eudract:2014-005623-27
Results first posted: 2019-07-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in Weekly Vomiting Episodes	7 days prior to Day 1 for Baseline to 7 days prior to Week 12	Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.
Secondary	Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)	7 days prior to Day 1 for Baseline to 7 days prior to Week 12	The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to "no" (symptom) and 10 equating to "worst possible" (symptom). Early satiety was assessed on a 5-item scale with 1 being "Only 1 or 2 bites" and 5 being "All of a normal-sized meal"; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement.
Secondary	Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time	Baseline (Day 1) to Week 12	GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in Weekly Vomiting Episodes	7 days prior to Day 1 for Baseline to 7 days prior to Week 12	Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.	vomiting episodes per week	MEAN
SECONDARY	Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)	7 days prior to Day 1 for Baseline to 7 days prior to Week 12	FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.	score on a scale	MEAN
SECONDARY	Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time	Baseline (Day 1) to Week 12	FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.	minutes	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Placebo	Baseline	5.7	Standard Deviation 6.0	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 10 μg	Baseline	7.7	Standard Deviation 17.2	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 30 μg	Baseline	6.9	Standard Deviation 10.3	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 100 μg	Baseline	4.8	Standard Deviation 5.2	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Placebo	Change from Baseline to Week 12	-2.9	Standard Deviation 5.8	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 10 μg	Change from Baseline to Week 12	-3.7	Standard Deviation 12.5	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 30 μg	Change from Baseline to Week 12	-3.8	Standard Deviation 7.6	vomiting episodes per week
Change From Baseline to Week 12 in Weekly Vomiting Episodes	Relamorelin 100 μg	Change from Baseline to Week 12	-1.1	Standard Deviation 13.5	vomiting episodes per week
Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)	Placebo	Baseline	21.4	Standard Deviation 6.7	score on a scale
Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)	Relamorelin 10 μg	Baseline	21.8	Standard Deviation 6.9	score on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	104
Overall Study	STARTED	Relamorelin 10 μg	98
Overall Study	STARTED	Relamorelin 30 μg	109
Overall Study	STARTED	Relamorelin 100 μg	82
Overall Study	Full Analysis Set (FAS)	Placebo	104
Overall Study	Full Analysis Set (FAS)	Relamorelin 10 μg	98
Overall Study	Full Analysis Set (FAS)	Relamorelin 30 μg	109
Overall Study	Full Analysis Set (FAS)	Relamorelin 100 μg	81
Overall Study	COMPLETED	Placebo	92
Overall Study	COMPLETED	Relamorelin 10 μg	86

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events156

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	104
other	Diarrhoea	Gastrointestinal disorders	Relamorelin 10 μg	4	98
other	Diarrhoea	Gastrointestinal disorders	Relamorelin 30 μg	7	109
other	Diarrhoea	Gastrointestinal disorders	Relamorelin 100 μg	6	82
other	Urinary tract infection	Infections and infestations	Placebo	7	104
other	Urinary tract infection	Infections and infestations	Relamorelin 10 μg	7	98
other	Urinary tract infection	Infections and infestations	Relamorelin 30 μg	8	109
other	Urinary tract infection	Infections and infestations	Relamorelin 100 μg	6	82
other	Blood glucose increased	Investigations	Placebo	1	104
other	Blood glucose increased	Investigations	Relamorelin 10 μg	3	98

1 to 10 of 156Source ClinicalTrials.gov

See all 156 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	104
Total, all-cause mortality	Relamorelin 10 μg	0	98
Total, all-cause mortality	Relamorelin 30 μg	0	109
Total, all-cause mortality	Relamorelin 100 μg	1	82
Total, other adverse events	Placebo	13	104
Total, other adverse events	Relamorelin 10 μg	21	98
Total, other adverse events	Relamorelin 30 μg	30	109
Total, other adverse events	Relamorelin 100 μg	28	82
Total, serious adverse events	Placebo	8	104
Total, serious adverse events	Relamorelin 10 μg	7	98

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28760384	DERIVED	PubMed
32301137	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02357420

GET https://conductscience.org/api/trials/v1/NCT02357420/results?page=2

API reference For AI assistants