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Comparison · NCT03426345-2930289e

Relamorelin 10 μg vs Placebo: Number of Participants With Clinically Meaningful Trends for Vital Signs

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Relamorelin 10 μg vs Placebo: Number of Participants With Clinically Meaningful Trends for Vital Signs. Trial comparisons, record NCT03426345-2930289e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03426345-2930289e

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0242wilson
Risk in group 2000.0246wilson
Risk difference, group 1 minus group 20-0.02460.0242newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Relamorelin 10 μgFollowing a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.0155OG001
Group 2PlaceboFollowing a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.0152OG000

Outcome

Type
SECONDARY
Title
Number of Participants With Clinically Meaningful Trends for Vital Signs
Description
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Time frame
Up to 12 weeks
Population
Safety Population included all participants who received ≥1 administration of double-blind study treatment.

Source ClinicalTrials.gov

Trial

Title
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
NCT number
NCT03426345
Phases
PHASE3
Conditions
Gastroparesis, Diabetes Mellitus
Interventions
Placebo, Relamorelin
Lead sponsor
Allergan
Results first posted
2021-08-06

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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