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TAK-906 Maleate PlaceboWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2416 TAK-906 Maleate Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018589 Gastroparesis NIH 0.45

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002578 Gastroparesis HPO 0.45

There is one clinical trial.

Clinical Trials

1 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor D2/D3 Antagonist, TAK-906 for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis

The purpose of this study is to assess the efficacy and safety of treatment with various dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

NCT03544229 Diabetic Gastroparesis Idiopathic Gastroparesis Drug: TAK-906 Maleate Drug: TAK-906 Maleate Placebo
MeSH:Gastroparesis
HPO:Gastroparesis

Primary Outcomes

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 12

Secondary Outcomes

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: Percentage of Participants with At least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12

Time: Baseline and Week 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: The 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 12

Description: 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 12

Description: Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD Score ≥2]).

Measure: Percentage of Symptomatic Weeks

Time: Up to 12 weeks

Description: 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 12

Description: 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 Severity of Gastroparesis Symptoms Score at Week 12

Time: Baseline and Week 12

Related HPO nodes (Using clinical trials)

HP:0002578: Gastroparesis
Genes 27
PINK1 TWNK POLG PARK7 TMEM70 TWNK LRRK2 POLG2 SNCA HTRA2 POLG POLG2 ATP7A PODXL POLG TYMP VPS13C POLG SLC25A4 SON TWNK SYNJ1 RRM2B UCHL1 PRKN DNAJC6 POLG
Protein Mutations 0
SNP 0