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Comparison · NCT03197662-sae

Experimental: Intranasal Oxytocin (IN-OXT) vs Placebo Comparator: Matched Placebo: serious adverse events

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. Experimental: Intranasal Oxytocin (IN-OXT) vs Placebo Comparator: Matched Placebo: serious adverse events. Trial comparisons, record NCT03197662-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03197662-sae

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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 1000.204wilson
Risk in group 2000.184wilson
Risk difference, group 1 minus group 20-0.1840.204newcombe 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 harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Experimental: Intranasal Oxytocin (IN-OXT)
Syntocinon (synthetic oxytocin) will be used in this protocol. Each subject will receive a dose of 16 IU QD and will be instructed to inhale 2 puffs per nostril (4 IU each).~Intranasal Oxytocin (IN-OXT): Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril every day (4 IU each). If needed, treatment will be titrated due to side effects or non-response.
015EG000
Group 2Placebo Comparator: Matched Placebo
Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril (4 IU each).~Matched Placebo: Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril every day (4 IU each). If needed, treatment will be titrated due to side effects or non-response.
017EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse event data for each subject was collected from baseline to completion of endpoint collection, 10 weeks total

Source ClinicalTrials.gov

Trial

Title
Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome
NCT number
NCT03197662
Phases
PHASE2
Conditions
Prader-Willi Syndrome, Hyperphagia
Interventions
Intranasal Oxytocin (IN-OXT), Matched Placebo
Lead sponsor
Eric Hollander
Results first posted
2025-02-07

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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