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Comparison · NCT05073679-sae

Intervention vs Control: 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. Intervention vs Control: serious adverse events. Trial comparisons, record NCT05073679-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05073679-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 1000.434wilson
Risk in group 20.250.04560.699wilson
Risk difference, group 1 minus group 2-0.25-0.6990.23newcombe 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 treat, for one fewer participant with a serious adverse event on Intervention than on Control4from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Intervention
Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler~Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter
05EG000
Group 2ControlOpaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks~Control: Methylcellulose and gelatin capsule only14EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to 33 weeks for each participant.

Source ClinicalTrials.gov

Trial

Title
Oral Naltrexone In Pediatric Eating Disorders
NCT number
NCT05073679
Phases
PHASE2, PHASE3
Conditions
Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Purging (Eating Disorders), Impulsive Behavior, Eating Disorders, Bulimia Nervosa, Eating Disorders in Adolescence
Interventions
Naltrexone Hydrochloride, Control
Lead sponsor
Rosemary Claire Roden
Results first posted
2025-08-19

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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