Comparison · NCT01271933-8bfa7ff5
Pregabalin (Double Blind Phase) vs Placebo (Double Blind Phase): Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
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 (Double Blind Phase) vs Placebo (Double Blind Phase): Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event. Trial comparisons, record NCT01271933-8bfa7ff5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01271933-8bfa7ff5
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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 | 0.54 | 0.418 | 0.657 | wilson | |
| Risk in group 2 | 0.707 | 0.58 | 0.808 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.326 | 0.00564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.763 | 0.576 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.486 | 0.229 | 1.03 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pregabalin (Double Blind Phase) than on Placebo (Double Blind Phase) | 5.98 | 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 | Pregabalin (Double Blind Phase) | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | 34 | 63 | OG000 |
| Group 2 | Placebo (Double Blind Phase) | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | 41 | 58 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
- Description
Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.
- Time frame
- Randomization to Week 19
- Population
- FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.
Source ClinicalTrials.gov
Trial
- Title
- Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
- NCT number
- NCT01271933
- Phases
- PHASE3
- Conditions
- Fibromyalgia
- Interventions
- pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2018-09-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01271933?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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