Comparison · NCT01049217-18c8c0e5
Pregabalin vs Placebo: Number of Participants With Abnormal Laboratory Test Findings
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. Pregabalin vs Placebo: Number of Participants With Abnormal Laboratory Test Findings. Trial comparisons, record NCT01049217-18c8c0e5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01049217-18c8c0e5
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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 | 0.917 | 0.867 | 0.949 | wilson | |
| Risk in group 2 | 0.929 | 0.882 | 0.958 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0123 | -0.0698 | 0.0444 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.987 | 0.93 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.841 | 0.388 | 1.82 | log | |
| Number needed to treat, for one fewer participant with the outcome on Pregabalin than on Placebo | 81.3 | 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 | Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period. | 165 | 180 | OG000 |
| Group 2 | Placebo | Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period. | 170 | 183 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Abnormal Laboratory Test Findings
- Description
Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.
- Time frame
- Screening up to Week 17
- Population
Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. N (number of participants analyzed) signifies those participants who were evaluable for this measure.
Source ClinicalTrials.gov
Trial
- Title
- Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
- NCT number
- NCT01049217
- Phases
- PHASE3
- Conditions
- Neuropathy
- Interventions
- pregabalin, placebo
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-07-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01049217?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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