Comparison · NCT00371033-0fa5ac74
1-Pregabalin vs 2-Placebo: Moderately or Markedly Improve on Global Response Assessment (GRA)
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-Pregabalin vs 2-Placebo: Moderately or Markedly Improve on Global Response Assessment (GRA). Trial comparisons, record NCT00371033-0fa5ac74. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00371033-0fa5ac74
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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 | 0.312 | 0.254 | 0.376 | wilson | |
| Risk in group 2 | 0.189 | 0.126 | 0.274 | wilson | |
| Risk difference, group 1 minus group 2 | 0.123 | 0.0206 | 0.213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.65 | 1.06 | 2.57 | log | |
| Odds ratio, group 1 over group 2 | 1.95 | 1.11 | 3.43 | log | |
| Number needed to treat, for one more participant with the outcome on 1-Pregabalin than on 2-Placebo | 8.11 | 4.69 | 48.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 1-Pregabalin | Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. | 68 | 218 | OG000 |
| Group 2 | 2-Placebo | Men were randomly assigned to receive pregabalin or an identical placebo in a 2:1 ratio and were treated for 6 weeks. Treatment dosage was escalated as follows: 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks. Men assigned to receive placebo underwent a similar escalation in the number of capsules prescribed. | 20 | 106 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Moderately or Markedly Improve on Global Response Assessment (GRA)
- Description
The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.
- Time frame
- 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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