Trial · NCT01903005
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
NCT01903005, Phase 4, Completed, Orexo AB; results first posted 2015-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence. Trials, record NCT01903005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01903005
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
- NCT number
- NCT01903005
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 668 participants, actual
- Lead sponsor
- Orexo AB
- Conditions
- Opioid Dependence, on Agonist Therapy
- Interventions
- Higher bioavailability BNX sublingual tablets
- First posted
- 2013-07-19
- Last updated
- 2015-10-28
- Results first posted
- 2015-10-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Reporting Treatment-Emergent Adverse Events | Day 1 through week 24 | Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets |
| Primary | Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events | Day 1 through week 24 | Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets |
| Primary | Number of Patients Reporting Treatment-Emergent Serious Adverse Events | Day 1 throught week 24 | Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets |
| Primary | Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events | Day 1 through week 24 | Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets |
| Secondary | Retention in Treatment in the Safety Population | Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24 | Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit) |
| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint | Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS |
| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint | Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS |
| Secondary | Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores | Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint | Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving |
| Secondary | Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) | Study Endpoint | Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end |
| Secondary | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP | Week 24 | Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work? |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Retention in Treatment in the Safety Population | Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24 | Safety population | participants | NUMBER |
| SECONDARY | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint | Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data | units on a scale | MEAN |
| SECONDARY | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score | Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint | Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data | units on a scale | MEAN |
| SECONDARY | Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores | Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint | Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data | units on a scale | MEAN |
| SECONDARY | Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP) | Study Endpoint | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed | percentage of patients | NUMBER |
| SECONDARY | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP | Week 24 | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | hours | MEAN |
| SECONDARY | Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP | Week 24 | Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed | units on a scale | MEAN |
| PRIMARY | Number of Patients Reporting Treatment-Emergent Adverse Events | Day 1 through week 24 | Safety population | participants | NUMBER |
| PRIMARY | Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events | Day 1 through week 24 | Safety population | participants | NUMBER |
| PRIMARY | Number of Patients Reporting Treatment-Emergent Serious Adverse Events | Day 1 throught week 24 | Safety population | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Retention in Treatment in the Safety Population | Safety Population | Week 4 | 563 | 95% Confidence Interval 545 to 581 | participants |
| Retention in Treatment in the Safety Population | Safety Population | Week 8 | 483 | 95% Confidence Interval 460 to 505 | participants |
| Retention in Treatment in the Safety Population | Safety Population | Week 12 | 425 | 95% Confidence Interval 401 to 450 | participants |
| Retention in Treatment in the Safety Population | Safety Population | Week 16 | 383 | 95% Confidence Interval 358 to 408 | participants |
| Retention in Treatment in the Safety Population | Safety Population | Week 20 | 333 | 95% Confidence Interval 308 to 358 | participants |
| Retention in Treatment in the Safety Population | Safety Population | Week 24 | 292 | 95% Confidence Interval 267 to 317 | participants |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Safety Population | Day 1 (n=658) | -12.0 | 95% Confidence Interval -12.3 to -11.6 | units on a scale |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Safety Population | Week 4 (n=557) | -12.2 | 95% Confidence Interval -12.6 to -11.8 | units on a scale |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Safety Population | Week 8 (n=477) | -12.7 | 95% Confidence Interval -13.1 to -12.3 | units on a scale |
| Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score | Safety Population | Week 12 (n=423) | -12.9 | 95% Confidence Interval -13.4 to -12.5 | units on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Population | 665 | |
| Overall Study | COMPLETED | Safety Population | 292 | |
| Overall Study | NOT COMPLETED | Safety Population | 373 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Safety Population | 20 | 665 | 22 |
| other | Headache | Nervous system disorders | Safety Population | 21 | 665 | 22 |
| serious | Heroin toxicity | Injury, poisoning and procedural complications | Safety Population | 1 | 665 | 1 |
| serious | Hypertensive and atherosclerotic cardiovascular disease | Cardiac disorders | Safety Population | 1 | 665 | 1 |
| serious | Non-small cell lung cancer | Respiratory, thoracic and mediastinal disorders | Safety Population | 1 | 665 | 1 |
| serious | Respiratory syncytial virus bronchitis | Infections and infestations | Safety Population | 1 | 665 | 1 |
| serious | Depression | Psychiatric disorders | Safety Population | 2 | 665 | 2 |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Safety Population | 1 | 665 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Safety Population | 1 | 665 | 1 |
| serious | Anal abscess | Infections and infestations | Safety Population | 1 | 665 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Population | ||
| Total, other adverse events | Safety Population | 41 | 665 |
| Total, serious adverse events | Safety Population | 15 | 665 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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