Comparison · NCT00371033-620ecd04
1-Pregabalin vs 2-Placebo: Decrease in the NIH-CPSI Total Score by at Least 6 Points
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. 1-Pregabalin vs 2-Placebo: Decrease in the NIH-CPSI Total Score by at Least 6 Points. Trial comparisons, record NCT00371033-620ecd04. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00371033-620ecd04
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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 | 0.472 | 0.407 | 0.539 | wilson | |
| Risk in group 2 | 0.358 | 0.274 | 0.453 | wilson | |
| Risk difference, group 1 minus group 2 | 0.114 | -0.00106 | 0.222 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.985 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.994 | 2.58 | log | |
| Number needed to treat, for one more participant with the outcome on 1-Pregabalin than on 2-Placebo | 8.77 | 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-Pregabalin | Randomized to Pregabalin | 103 | 218 | OG000 |
| Group 2 | 2-Placebo | Randomized to placebo | 38 | 106 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Decrease in the NIH-CPSI Total Score by at Least 6 Points
- Description
Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
- Time frame
- Baseline and 6 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- NCT number
- NCT00371033
- Phases
- PHASE3
- Conditions
- Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- Interventions
- Pregabalin, Placebo
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2025-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00371033?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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