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Report for D018589: Gastroparesis NIH

(Synonyms: Gastroparesis)

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


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug2406 Relamorelin Wiki 0.77
drug2804 TAK-906 Maleate Placebo Wiki 0.45
drug2803 TAK-906 Maleate Wiki 0.45
drug2407 Relamorelin 10 μg Wiki 0.45
drug2122 Placebo Wiki 0.07

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002578 Gastroparesis HPO 1.00

There are 5 clinical trials

Clinical Trials


1 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

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.

NCT03285308 Gastroparesis Diabetes Mellitus Drug: Relamorelin Drug: Placebo
MeSH:Gastroparesis
HPO:Gastroparesis

Primary Outcomes

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 Weeks

Description: 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 Weeks

Secondary Outcomes

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

2 A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

A 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.

NCT03383146 Gastroparesis Diabetes Mellitus Drug: Relamorelin Drug: Placebo
MeSH:Gastroparesis
HPO:Gastroparesis

Primary Outcomes

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 12

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 52 in weekly average DGSSS

Time: Baseline to Week 52

Description: Incidence of AEs

Measure: Number of participants with adverse events (AEs)

Time: Baseline to Week 52

Description: 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 52

Description: 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 52

Description: The number of participants who experienced CS ECG values during the 52 week treatment period

Measure: Electrocardiogram (ECG) Heart Rate

Time: Baseline to Week 52

Description: The number of participants who experienced CS ECG values during the 52 week treatment period

Measure: ECG PR Interval

Time: Baseline to Week 52

Description: The number of participants who experienced CS ECG values during the 52 week treatment period

Measure: ECG QRS Interval

Time: Baseline to Week 52

Description: The number of participants who experienced CS ECG values during the 52 week treatment period

Measure: ECG QT Interval

Time: Baseline to Week 52

Description: The number of participants who experienced CS ECG values during the 52 week treatment period

Measure: ECG QTc Interval

Time: Baseline to Week 52

Description: 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 52

Description: 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 52

3 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

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.

NCT03426345 Gastroparesis Diabetes Mellitus Drug: Relamorelin Drug: Placebo
MeSH:Gastroparesis
HPO:Gastroparesis

Primary Outcomes

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 12

Description: 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 12

Secondary Outcomes

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

4 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

5 Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

This 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.

NCT03786380 Gastroparesis Drug: Relamorelin 10 μg
MeSH:Gastroparesis
HPO:Gastroparesis

Primary Outcomes

Measure: Proportion of adverse events in participants

Time: Through study completion: up to 5 years

Measure: Proportion of abnormal clinical laboratory values

Time: Baseline and every 3 months for up to 5 years

Measure: Proportion of abnormal vital signs

Time: Baseline and every 3 months for up to 5 years

Measure: Propotion of abnormal electrocardiograms

Time: Baseline and final visit: up to 5 years


HPO Nodes