Comparison · NCT01270828-0329c3eb
Pregabalin CR DB vs Placebo DB: Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
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. Pregabalin CR DB vs Placebo DB: Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results. Trial comparisons, record NCT01270828-0329c3eb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01270828-0329c3eb
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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 | 0.236 | 0.183 | 0.298 | wilson | |
| Risk in group 2 | 0.424 | 0.359 | 0.493 | wilson | |
| Risk difference, group 1 minus group 2 | -0.189 | -0.275 | -0.0984 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.555 | 0.414 | 0.743 | log | |
| Odds ratio, group 1 over group 2 | 0.418 | 0.274 | 0.638 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pregabalin CR DB than on Placebo DB | 5.3 | 3.64 | 10.2 | 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 | Pregabalin CR DB | Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (\>30 - \<60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR. | 49 | 208 | OG000 |
| Group 2 | Placebo DB | Participants received matching placebo | 87 | 205 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
- Description
A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:~1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score~2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.
- Time frame
- 13 Weeks
- Population
- The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase
Source ClinicalTrials.gov
Trial
- Title
- Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
- NCT number
- NCT01270828
- Phases
- PHASE3
- Conditions
- Post Herpetic Neuralgia
- Interventions
- Pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2016-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01270828?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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