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The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.
Nonprobability sampling was done by invitation to volunteer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine/naloxone | Drug | 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study | month 6, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Dosing of Suboxone (Buprenorphine Plus Naloxone) | One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose. | day 1, month 6, month 12 |
| Dispensing of Suboxone (Buprenorphine Plus Naloxone) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients on substitution therapy for opioid dependence willing to switch to Suboxone
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| Name | Affiliation | Role |
|---|---|---|
| Gabriele Fischer, Prof. Dr. | Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| (Multiple sites in Austria) => Coordinating CRO: H&P GmbH | Vienna | 1070 | Austria |
339 patients were enrolled, 32 datasets were excluded from analysis because of missing baseline assessment and/or missing final/dropout documentation = 307 eligible datasets were used for final general and safety analysis
Recruitment period: May 2008 - December 2009 Patients were eligible for observation if the transfer from an ongoing opioid dependence therapy to Suboxone was indicated and planned prior to enrollment to P05444 by the treating physician.
Multiple sites in Austria: general practitioners, clinics/outpatient clinics, drug counseling centers, prisons
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid Dependent Patients | Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Opioid Dependent Patients | Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention Rate | The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study | All eligible datasets were included in analysis population. | Posted | Oct 2011 | Number | 95% Confidence Interval | percentage of patients | month 6, month 12 |
|
|
Adverse events were collected for total observational time of each patient: from start of treatment until end of observation or date of early discontinuation, respectively - maximum period 1 year
For description of safety data all patients enrolled and exposed to Suboxone® for at least one day(N=339) were included in the safety analysis
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Opioid Dependent Patients | Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment | Hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Director | RB Pharmaceuticals | +1 (804) 379 1090 | Tim.Baxter@reckittbenckiser.com |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other) |
| month 6, month 12 |
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Dosing of Suboxone (Buprenorphine Plus Naloxone) | One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose. | All participants with eligible datasets were included in the final analysis | Posted | Oct 2011 | Mean | Standard Deviation | Dose of Suboxone® in mg | day 1, month 6, month 12 |
|
|
|
| Secondary | Dispensing of Suboxone (Buprenorphine Plus Naloxone) | Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other) | All participants with eligible datasets were included in the final analysis | Posted | Number | Participants | month 6, month 12 |
|
|
|
| 2 |
| 339 |
| 49 |
| 339 |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Non-systematic Assessment | no further information available |
|
| General disorders and administration site conditions | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
Study results belong to the Sponsor only, all investigators are not allowed to publish study results without permission of the Sponsor.
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Month 6: Once weekly |
|
| Month 6: Monthly |
|
| Month 6: Other |
|
| N patients with dispensing data at month 12 |
|
| Month 12: Daily |
|
| Month 12: Biweekly |
|
| Month 12: Once weekly |
|
| Month 12: Monthly |
|
| Month 12: Other |
|