Trial · NCT03420781
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes 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 analysis. Number analyzed is the number of participants with data available for analysis at the given timepoint. | vomiting episodes per week | MEAN |
| SECONDARY | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 50 weeks) | Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Up to 46 weeks | Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Meaningful Trends for Vital Signs | Up to 46 weeks | Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Up to 46 weeks | Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Up to 46 weeks | Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Overall number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-relamorelin Antibody Testing Results | Up to 46 weeks | Due to limitations at the vendor's end, the final analysis data could not be obtained. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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