Comparison · NCT02025725-sae
10 mg Metoclopramide Nasal Spray vs Placebo Nasal Spray: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 10 mg Metoclopramide Nasal Spray vs Placebo Nasal Spray: serious adverse events. Trial comparisons, record NCT02025725-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02025725-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0294 | 0.0101 | 0.0829 | wilson | |
| Risk in group 2 | 0.0194 | 0.00534 | 0.0681 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00999 | -0.0424 | 0.0653 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 0.258 | 8.88 | log | |
| Odds ratio, group 1 over group 2 | 1.53 | 0.25 | 9.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 10 mg Metoclopramide Nasal Spray than on Placebo Nasal Spray | 100 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 10 mg Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime for 4 weeks~Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide | 3 | 102 | EG000 |
| Group 2 | Placebo Nasal Spray | Placebo Nasal Spray 30 minutes before meals and at bedtime for 4 weeks~Placebo Nasal Spray: nasal spray formulation with vehicle only | 2 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Event (AE) data were collected through the last study visit (Day 28). Serious AEs (SAEs) were collected for up to 30 days after the final dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
- NCT number
- NCT02025725
- Phases
- PHASE3
- Conditions
- Diabetic Gastroparesis
- Interventions
- Metoclopramide Nasal Spray, Placebo Nasal Spray
- Lead sponsor
- Evoke Pharma
- Results first posted
- 2020-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02025725?tab=results
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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