Trial · NCT03426345
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
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) | 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 |
| SECONDARY | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Baseline (Day 1) up to 12 weeks | Safety Population included all participants who received ≥1 administration of double-blind study treatment. Overall 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 Anti-relamorelin Antibody Testing Results by Visit | Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84) | Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=155 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. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03426345/outcomes