Trial · NCT03420781
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
NCT03420781, Phase 3, Terminated, Allergan; results first posted 2021-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03. Trials, record NCT03420781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03420781
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
- NCT number
- NCT03420781
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 467 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Gastroparesis, Diabetes Mellitus
- Interventions
- Placebo, Relamorelin
- First posted
- 2018-02-05
- Last updated
- 2021-12-22
- Results first posted
- 2021-12-22
Source ClinicalTrials.gov
Registered outcomes17
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) of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study | 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 in the previous studies. |
| Primary | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the 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 first 12-weeks of the 40-week Treatment Period. |
| Secondary | Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Secondary | Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Secondary | Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 first 12-weeks of the 40-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. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Secondary | Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 first 12-weeks of the 40-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). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Secondary | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 of the previous studies. |
| Secondary | Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period | Week 37 to Week 40 | 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 the last 4 weeks of the 40-week Treatment Period. |
| Secondary | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | 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. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Secondary | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46) | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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) of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study | Modified-intent-to-treat (mITT) Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint. | score on a scale | MEAN |
| PRIMARY | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Week 6 to Week 12 | mITT Population included all participants in the ITT population 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 First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | mITT Population included all participants in the ITT population 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 First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | mITT Population included all participants in the ITT population 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 First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | mITT Population included all participants in the ITT population 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 First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period | Week 37 to Week 40 | mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint. | vomiting episodes per week | MEAN |
| SECONDARY | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46) | RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint. | score on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group251
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) of the Treatment Period | Treatment Period: Placebo | Baseline | 24.9 | Standard Deviation 5.65 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Treatment Period: Relamorelin 10 μg | Baseline | 24.8 | Standard Deviation 6.28 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Treatment Period: Placebo | Change from Baseline to Week 12 | -11.9 | Standard Deviation 9.43 | score on a scale |
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Treatment Period: Relamorelin 10 μg | Change from Baseline to Week 12 | -11.2 | Standard Deviation 9.00 | score on a scale |
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Placebo | 29.4 | percentage of participants | ||
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Relamorelin 10 μg | 21.4 | percentage of participants | ||
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Placebo | 46.0 | percentage of participants | ||
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Relamorelin 10 μg | 43.2 | percentage of participants | ||
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Placebo | 40.4 | percentage of participants | ||
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Treatment Period: Relamorelin 10 μg | 39.7 | percentage of participants |
1 to 10 of 251Source ClinicalTrials.gov
See all 251 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (40 Weeks) | STARTED | Treatment Period: Placebo | 236 | |
| Treatment Period (40 Weeks) | STARTED | Treatment Period: Relamorelin 10 μg | 231 | |
| Treatment Period (40 Weeks) | STARTED | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | |
| Treatment Period (40 Weeks) | STARTED | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | |
| Treatment Period (40 Weeks) | STARTED | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 | |
| Treatment Period (40 Weeks) | Safety Population | Treatment Period: Placebo | 235 | |
| Treatment Period (40 Weeks) | Safety Population | Treatment Period: Relamorelin 10 μg | 231 | |
| Treatment Period (40 Weeks) | Safety Population | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | |
| Treatment Period (40 Weeks) | Safety Population | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | |
| Treatment Period (40 Weeks) | Safety Population | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events390
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 | Urinary tract infection | Infections and infestations | Treatment Period: Placebo | 13 | 235 | |
| other | Urinary tract infection | Infections and infestations | Treatment Period: Relamorelin 10 μg | 16 | 231 | |
| other | Urinary tract infection | Infections and infestations | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | 91 | |
| other | Urinary tract infection | Infections and infestations | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | 59 | |
| other | Urinary tract infection | Infections and infestations | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 | 43 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Treatment Period: Placebo | 7 | 235 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Treatment Period: Relamorelin 10 μg | 12 | 231 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | 91 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | 59 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 | 43 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period: Placebo | 3 | 236 |
| Total, all-cause mortality | Treatment Period: Relamorelin 10 μg | 2 | 231 |
| Total, all-cause mortality | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | 91 |
| Total, all-cause mortality | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | 59 |
| Total, all-cause mortality | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 | 43 |
| Total, other adverse events | Treatment Period: Placebo | 18 | 235 |
| Total, other adverse events | Treatment Period: Relamorelin 10 μg | 27 | 231 |
| Total, other adverse events | Randomized Withdrawal Period: Placebo Then Relamorelin 10 μg | 0 | 91 |
| Total, other adverse events | Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 0 | 59 |
| Total, other adverse events | Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 0 | 43 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 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.
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.
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