Comparison · NCT00765895-sae
Nortriptyline 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. Nortriptyline vs Placebo: serious adverse events. Trial comparisons, record NCT00765895-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00765895-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 | 0.0769 | 0.0333 | 0.168 | wilson | |
| Risk in group 2 | 0.0154 | 0.00272 | 0.0821 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0615 | -0.0182 | 0.153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5 | 0.601 | 41.6 | log | |
| Odds ratio, group 1 over group 2 | 5.33 | 0.605 | 47 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Nortriptyline than on Placebo | 16.3 | 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 | Nortriptyline | Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week | 5 | 65 | EG000 |
| Group 2 | Placebo | No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week | 1 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
Source ClinicalTrials.gov
Trial
- Title
- Nortriptyline for Idiopathic Gastroparesis
- NCT number
- NCT00765895
- Phases
- PHASE3
- Conditions
- Idiopathic Gastroparesis
- Interventions
- Nortriptyline Hydrochloride, Placebo (for nortriptyline)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2015-04-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00765895?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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