Comparison · NCT00522041-sae
Cellegesic (Nitroglycerin 0.4%) vs 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
Cite this record
ConductScience Library. Cellegesic (Nitroglycerin 0.4%) vs Placebo: serious adverse events. Trial comparisons, record NCT00522041-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00522041-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 | 0.0163 | 0.00447 | 0.0574 | wilson | |
| Risk in group 2 | 0.00806 | 0.00143 | 0.0443 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0082 | -0.0299 | 0.0498 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.02 | 0.185 | 21.9 | log | |
| Odds ratio, group 1 over group 2 | 2.03 | 0.182 | 22.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cellegesic (Nitroglycerin 0.4%) than on Placebo | 122 | 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 | Cellegesic (Nitroglycerin 0.4%) | Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. | 2 | 123 | EG000 |
| Group 2 | Placebo | Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. | 1 | 124 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
- NCT number
- NCT00522041
- Phases
- PHASE3
- Conditions
- Fissure in Ano, Pain
- Interventions
- Cellegesic, Placebo
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2016-11-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00522041?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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