Trial · NCT03426345
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
NCT03426345, Phase 3, Terminated, Allergan; results first posted 2021-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02. Trials, record NCT03426345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03426345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
- NCT number
- NCT03426345
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 311 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Gastroparesis, Diabetes Mellitus
- Interventions
- Placebo, Relamorelin
- First posted
- 2018-02-08
- Last updated
- 2021-08-06
- Other registries' IDs
- eudract:2017-002177-20
- Results first posted
- 2021-08-06
Source ClinicalTrials.gov
Registered outcomes12
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 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Number of Participants With Clinically Meaningful Trends for Vital Signs | Up to 12 weeks | Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant. |
| Secondary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline (Day-14 to Day-1) to Week 12 | Modified Intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | score on a scale | MEAN |
| PRIMARY | 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 | mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | 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) | mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | Up to approximately 16 weeks | Safety Population included all participants who received ≥1 administration of double-blind study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Trends for Vital Signs | Up to 12 weeks | Safety Population included all participants who received ≥1 administration of double-blind study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Up to 12 weeks | Safety Population included all participants who received ≥1 administration of double-blind study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group104
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 the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Placebo | Baseline | 23.4 | Standard Deviation 5.40 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Relamorelin 10 μg | Baseline | 24.9 | Standard Deviation 6.15 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Placebo | Change from Baseline to Week 12 | -9.3 | Standard Deviation 10.21 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Relamorelin 10 μg | Change from Baseline to Week 12 | -10.2 | Standard Deviation 9.24 | score on a scale |
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Placebo | 19.1 | percentage of participants | ||
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Relamorelin 10 μg | 18.7 | percentage of participants | ||
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Placebo | 32.9 | percentage of participants | ||
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Relamorelin 10 μg | 38.1 | percentage of participants | ||
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Placebo | 27.0 | percentage of participants | ||
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Relamorelin 10 μg | 36.1 | percentage of participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 155 | |
| Overall Study | STARTED | Relamorelin 10 μg | 156 | |
| Overall Study | Safety Population | Placebo | 152 | |
| Overall Study | Safety Population | Relamorelin 10 μg | 155 | |
| Overall Study | COMPLETED | Placebo | 137 | |
| Overall Study | COMPLETED | Relamorelin 10 μg | 139 | |
| Overall Study | NOT COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Relamorelin 10 μg | 17 |
Source ClinicalTrials.gov
Adverse events46
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 152 | |
| other | Diarrhoea | Gastrointestinal disorders | Relamorelin 10 μg | 5 | 155 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 5 | 152 | |
| other | Urinary tract infection | Infections and infestations | Relamorelin 10 μg | 9 | 155 | |
| serious | Cardiac failure congestive | Cardiac disorders | Placebo | 1 | 152 | |
| serious | Cardiac failure congestive | Cardiac disorders | Relamorelin 10 μg | 1 | 155 | |
| serious | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 152 | |
| serious | Abdominal pain | Gastrointestinal disorders | Relamorelin 10 μg | 1 | 155 | |
| serious | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 152 | |
| serious | Diarrhoea | Gastrointestinal disorders | Relamorelin 10 μg | 1 | 155 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 155 |
| Total, all-cause mortality | Relamorelin 10 μg | 0 | 156 |
| Total, other adverse events | Placebo | 14 | 152 |
| Total, other adverse events | Relamorelin 10 μg | 13 | 155 |
| Total, serious adverse events | Placebo | 6 | 152 |
| Total, serious adverse events | Relamorelin 10 μg | 8 | 155 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Relamorelin 10 μg vs Placebo: Number of Participants With Clinically Meaningful Trends for Vital Signs | Trial comparisons |
| Relamorelin 10 μg vs Placebo: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | Trial comparisons |
| Relamorelin 10 μg vs Placebo: Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Trial comparisons |
| Relamorelin 10 μg vs Placebo: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Trial comparisons |
| Relamorelin 10 μg vs Placebo: deaths from any cause | Trial comparisons |
| Relamorelin 10 μg vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT03426345
GET https://conductscience.org/api/trials/v1/NCT03426345/results?page=2