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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3312 | Relamorelin Wiki | 0.77 |
| drug3865 | TAK-906 Maleate Placebo Wiki | 0.45 |
| drug3313 | Relamorelin 10 μg Wiki | 0.45 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 5 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 12The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.
Description: The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).
Measure: Change From Baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).
Measure: Percentage of Participants with At Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD nausea symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD early satiety symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD postprandial fullness symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD upper abdominal pain symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 Time: Baseline and Week 12Description: The vomiting score assesses the number of vomiting episodes during the day.
Measure: Change from Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD gastroparesis symptoms score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD bloating severity scale score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Bloating Severity Scale Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD total score quantifies the incidence and severity of symptoms, specifically nausea, early satiety, postprandial fullness, upper abdominal pain, bloating, and vomiting.
Measure: Change from Baseline in the ANMS GCSI-DD Total Score at Week 12 Time: Baseline and Week 12Description: Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD score ≥2] during 12 weeks of treatment.
Measure: Percentage of Symptomatic Weeks Time: Up to 12 weeksDescription: PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation). Higher scores indicate higher symptom severity.
Measure: Change from Baseline in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Total Score at Week 12 Time: Baseline and Week 12This open-label study is to assess the safety of continued treatment with Relamorelin for participants who previously completed the RLM-MD-03 or RLM-MD-04 study and to provide treatment for these participants until Relamorelin becomes commercially available or the Sponsor terminates development.
Alphabetical 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.
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