Comparison · NCT01848054-4e522003
BNX Sublingual Tablets Induction vs Buprenorphine Induction: Retention in Treatment in the Full Analysis Population
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. BNX Sublingual Tablets Induction vs Buprenorphine Induction: Retention in Treatment in the Full Analysis Population. Trial comparisons, record NCT01848054-4e522003. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01848054-4e522003
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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 | 0.852 | 0.787 | 0.899 | wilson | |
| Risk in group 2 | 0.948 | 0.901 | 0.974 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0968 | -0.166 | -0.0301 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.898 | 0.833 | 0.968 | log | |
| Odds ratio, group 1 over group 2 | 0.312 | 0.135 | 0.722 | log | |
| Number needed to treat, for one fewer participant with the outcome on BNX Sublingual Tablets Induction than on Buprenorphine Induction | 10.3 | 6.03 | 33.3 | from the risk difference interval |
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 | BNX Sublingual Tablets Induction | Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label) | 132 | 155 | OG000 |
| Group 2 | Buprenorphine Induction | Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label) | 147 | 155 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Retention in Treatment in the Full Analysis Population
- Description
Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.
- Time frame
- Day 3
- Population
- Full analysis population; patients with missing data were excluded from the analysis
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
- NCT number
- NCT01848054
- Phases
- PHASE3
- Conditions
- Opioid-Related Disorders, Opiate Dependence
- Interventions
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Lead sponsor
- Orexo AB
- Results first posted
- 2015-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01848054?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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