Comparison · NCT00124306-sae
1 - Amitriptyline vs 2 - 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. 1 - Amitriptyline vs 2 - Placebo: serious adverse events. Trial comparisons, record NCT00124306-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00124306-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 | 0.0148 | 0.00407 | 0.0524 | wilson | |
| Risk in group 2 | 0.0221 | 0.00753 | 0.0628 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00724 | -0.0494 | 0.0331 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.672 | 0.114 | 3.96 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.11 | 4.05 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 1 - Amitriptyline than on 2 - Placebo | 138 | 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 | 1 - Amitriptyline | Amitryptiline, increased during a 6-week period from 10 mg up to 75 mg, taken once daily for a total of 12 weeks.~Amitriptyline: Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg. During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet. | 2 | 135 | EG000 |
| Group 2 | 2 - Placebo | Placebo will be dosed exactly as the active arm and taken once daily for a total of 12 weeks.~Placebo: Placebo will be dosed exactly as active arm. | 3 | 136 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
- NCT number
- NCT00124306
- Phases
- PHASE3
- Conditions
- Bladder Diseases, Interstitial Cystitis
- Interventions
- Amitriptyline, Placebo
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2025-10-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00124306?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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