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RelamorelinWiki

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


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.10

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018589 Gastroparesis NIH 0.77

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002578 Gastroparesis HPO 0.77

There are 3 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


Related HPO nodes (Using clinical trials)