Trial · NCT02896296
Open-Label Treatment Extension Study
NCT02896296, Phase 3, Completed, Indivior Inc.; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Treatment Extension Study. Trials, record NCT02896296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02896296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Treatment Extension Study
- NCT number
- NCT02896296
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- Indivior Inc.
- Conditions
- Opioid Use Disorder, Opioid-related Disorders
- Interventions
- RBP-6000
- First posted
- 2016-09-12
- Last updated
- 2018-11-29
- Results first posted
- 2018-11-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | Day 1 up to Week 29 | TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Primary | Percentage Change From Baseline to Week 25 in Vital Signs | Day 1, Week 25 | Vital signs include: * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * pulse oximetry (%) * pulse rate (beats/min) * temperature (C) |
| Primary | Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values | Day 1 up to Week 25 | TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | Day 1 up to Week 29 | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage Change From Baseline to Week 25 in Vital Signs | Day 1, Week 25 | Safety analysis set. Participants with both baseline and Week 25 data are included. | percentage change from baseline | MEAN |
| PRIMARY | Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values | Day 1 up to Week 25 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | >=1 TEAE | 71 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | >=1 TEAE related to study drug | 14 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | >=1 serious TEAE | 5 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | >=1 serious study treatment-related TEAE | 0 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | Death | 0 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | >=1 severe TEAE | 8 | Participants | |
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | RBP-6000 (100/300 mg Flex) | TEAE leading to study treatment discontinuation | 1 | Participants | |
| Percentage Change From Baseline to Week 25 in Vital Signs | RBP-6000 (100/300 mg Flex) | Systolic blood pressure | 1.93 | Standard Deviation 11.208 | percentage change from baseline |
| Percentage Change From Baseline to Week 25 in Vital Signs | RBP-6000 (100/300 mg Flex) | Diastolic blood pressure | 2.61 | Standard Deviation 12.397 | percentage change from baseline |
| Percentage Change From Baseline to Week 25 in Vital Signs | RBP-6000 (100/300 mg Flex) | Pulse oximetry | 0.13 | Standard Deviation 1.377 | percentage change from baseline |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RBP-6000 (100/300 mg Flex) | 208 | |
| Overall Study | COMPLETED | RBP-6000 (100/300 mg Flex) | 166 | |
| Overall Study | NOT COMPLETED | RBP-6000 (100/300 mg Flex) | 42 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | RBP-6000 (100/300 mg Flex) | 3 | 208 | |
| serious | Seizure | Nervous system disorders | RBP-6000 (100/300 mg Flex) | 1 | 208 | |
| serious | Panic attack | Psychiatric disorders | RBP-6000 (100/300 mg Flex) | 1 | 208 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RBP-6000 (100/300 mg Flex) | 0 | 208 |
| Total, other adverse events | RBP-6000 (100/300 mg Flex) | 0 | 208 |
| Total, serious adverse events | RBP-6000 (100/300 mg Flex) | 5 | 208 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02896296
GET https://conductscience.org/api/trials/v1/NCT02896296/registered