Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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Navigate: Correlations HPO
There is one clinical trial.
The 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 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