Comparison · NCT01270828-8981ef9d
Pregabalin CR DB vs Placebo DB: Number of Participants With Loss of Therapeutic Response.
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: Number of Participants With Loss of Therapeutic Response. Trial comparisons, record NCT01270828-8981ef9d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01270828-8981ef9d
On this page
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 | 0.139 | 0.0989 | 0.193 | wilson | |
| Risk in group 2 | 0.307 | 0.248 | 0.374 | wilson | |
| Risk difference, group 1 minus group 2 | -0.168 | -0.246 | -0.0881 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.454 | 0.306 | 0.674 | log | |
| Odds ratio, group 1 over group 2 | 0.365 | 0.223 | 0.597 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pregabalin CR DB than on Placebo DB | 5.96 | 4.07 | 11.4 | 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. | 29 | 208 | OG000 |
| Group 2 | Placebo DB | Participants received matching placebo | 63 | 205 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Loss of Therapeutic Response.
- Description
Loss of Therapeutic Response (LTR) is defined as \<30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of \<30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.
- Time frame
- 13 Weeks
- Population
- The full analysis set (FAS) was the primary efficacy analysis set and 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01270828-8981ef9d