Comparison · NCT04218240-sae
PGB/LFX; vs Lofexidine and PLACEBO: serious adverse events
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. PGB/LFX; vs Lofexidine and PLACEBO: serious adverse events. Trial comparisons, record NCT04218240-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04218240-sae
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 | 0 | 0.0621 | wilson | |
| Risk in group 2 | 0.0313 | 0.00554 | 0.157 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0313 | -0.157 | 0.036 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on PGB/LFX; than on Lofexidine and PLACEBO | 32 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PGB/LFX; | oral tablet-lofexidine-active; oral capsule pregabalin-active Day 1: 0.54 mg lofexidine 3 times/day starting at 12p; plus 100 mg Pregabalin starting at 12p, and 4p, 200 mg at 8p. Day 2 through 5: 0.54 mg of lofexidine 4 times/day starting at 8a; plus 200 mg of pregabalin starting at 8am, 100 mg at 12p and 4p; and 200 mg at 8p.~Taper starts on Day 5 for lofexidine at 0.54 at 8a, 0.36 at 12p, 4p and 8p plus pregabalin starting at 8am at 100 mg, 75 mg at 12p, 4p, and 150 at 8p.~Taper on Day 6 for lofexidine at 0.36 at 8a, and 0.18 at 12p, 4p and 8p plus pregabalin starting at 8am at 50 mg, 25 mg at 12p, 4p, and 100 at 8p.~Taper on Day 7 for lofexidine at 0.18 mg at 8a; 12p; 4p and 8p plus pregabalin at 25 mg; 8am,12p, 4p, and 8p. | 0 | 58 | EG000 |
| Group 2 | Lofexidine and PLACEBO | oral tablet-lofexidine-active; oral capsule pregabalin-placebo Day 1: 0.54 mg lofexidine 3 times/day starting at 12p; plus 100 mg Pregabalin-placebo starting at 12p, and 4p, 200 mg at 8p. Day 2 through 5: 0.54 mg of lofexidine 4 times/day starting at 8a; plus 200 mg of pregabalin-placebo starting at 8am, 100 mg at 12p and 4p; and 200 mg at 8p.~Taper starts on Day 5 for lofexidine at 0.54 at 8a, 0.36 at 12p, 4p and 8p plus pregabalin-placebo starting at 8am at 100 mg, 75 mg at 12p, 4p, and 150 at 8p.~Taper on Day 6 for lofexidine at 0.36 at 8a, and 0.18 at 12p, 4p and 8p plus pregabalin-placebo starting at 8am at 50 mg, 25 mg at 12p, 4p, and 100 at 8p.~Taper on Day 7 for lofexidine at 0.18 mg at 8a; 12p; 4p and 8p plus pregabalin-placebo at 25 mg; 8am,12p, 4p, and 8p. | 1 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 15 days per subject
Source ClinicalTrials.gov
Trial
- Title
- Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
- NCT number
- NCT04218240
- Phases
- PHASE2
- Conditions
- Opioid Withdrawal
- Interventions
- Pregabalin 200 MG capsules, Placebo oral tablet, Lofexidine 0.18Mg Tab
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2024-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04218240?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/NCT04218240-sae