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Sections: Correlations,
Clinical Trials, and HPO
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There are 3 clinical trials
This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.
Description: Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.
Measure: To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment Time: Baseline, 12 WeeksDescription: Vomiting episodes will be patient-recorded daily using an electronic diary.
Measure: Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment Time: 12 WeeksDescription: A Nausea Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.
Measure: Percentage of Patients Meeting the Nausea Responder Criterion Time: Baseline to Week 12Description: An Abdominal Pain Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.
Measure: Percentage of Patients Meeting the Abdominal Pain Responder Criterion Time: Baseline to Week 12Description: A Bloating Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.
Measure: Percentage of Patients Meeting the Bloating Responder Criterion Time: Baseline to Week 12Description: A Postprandial Fullness Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites
Measure: Percentage of Patients Meeting the Postprandial Fullness Responder Criterion Time: Baseline to Week 12Description: The number of patients who experienced one or more TEAE during the 12 week treatment period.
Measure: Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) Time: Baseline to Week 12A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Description: Participants will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score using an electronic diary
Measure: Change from Baseline to Week 12 in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) Time: Baseline to Week 12Description: Participants will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score using an electronic diary
Measure: Change from Baseline to Week 52 in weekly average DGSSS Time: Baseline to Week 52Description: Incidence of AEs
Measure: Number of participants with adverse events (AEs) Time: Baseline to Week 52Description: The number of participants who experienced CS clinical laboratory values during the 52 week treatment period
Measure: Number of clinically significant (CS) clinical laboratory values Time: Baseline to Week 52Description: The number of participants who experienced CS vital sign values during the 52 week treatment period
Measure: Vital sign values (heart rate, blood pressure, respiratory rate, and temperature) Time: Baseline to Week 52Description: The number of participants who experienced CS ECG values during the 52 week treatment period
Measure: Electrocardiogram (ECG) Heart Rate Time: Baseline to Week 52Description: The number of participants who experienced CS ECG values during the 52 week treatment period
Measure: ECG PR Interval Time: Baseline to Week 52Description: The number of participants who experienced CS ECG values during the 52 week treatment period
Measure: ECG QRS Interval Time: Baseline to Week 52Description: The number of participants who experienced CS ECG values during the 52 week treatment period
Measure: ECG QT Interval Time: Baseline to Week 52Description: The number of participants who experienced CS ECG values during the 52 week treatment period
Measure: ECG QTc Interval Time: Baseline to Week 52Description: The number of participants who experienced CS HbA1c levels during the 52 week treatment period
Measure: Change from Baseline in hemoglobin A1c (HbA1c) levels Time: Baseline to Week 52Description: The number of participants who experienced anti-relamorelin antibodies during the 52 week treatment period
Measure: Change from Baseline in anti-relamorelin antibodies Time: Baseline to Week 52This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.
Description: Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.
Measure: To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment Time: Baseline to Week 12Description: Vomiting episodes will be patient-recorded daily using an electronic diary.
Measure: Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment Time: Baseline to Week 12Description: A Nausea Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.
Measure: Percentage of Patients Meeting the Nausea Responder Criterion Time: Baseline to Week 12Description: An Abdominal Pain Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal pain, and 10 meaning the worst possible abdominal pain.
Measure: Percentage of Patients Meeting the Abdominal Pain Responder Criterion Time: Baseline to Week 12Description: A Bloating Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.
Measure: Percentage of Patients Meeting the Bloating Responder Criterion Time: Baseline to Week 12Description: A Postprandial Fullness Responder is defined as an improvement 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 is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.
Measure: Percentage of Patients Meeting the Postprandial Fullness Responder Criterion Time: Baseline to Week 12Description: The number of patients who experienced one or more TEAE during the 12 week treatment period.
Measure: Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE) Time: Baseline to Week 12Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports