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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006686-17 |
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This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subutex®/Suboxone® | Experimental | Subutex® for first two days of study followed by Suboxone® for last 3 days of study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | 2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). | Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied" | Each treatment Day (post-dose on days 1-5) |
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Inclusion Criteria:
Exclusion Criteria:
Subject not eligible for treatment with Subutex® or Suboxone® according to the legal drug attachments.
Subject refusing to take the daily dose of the study medication under control in the center.
Subject unable to complete the evaluations.
Women who are pregnant or nursing.
Subject with a history of hypersensitivity to buprenorphine hydrochloride or naloxone hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.
Subject with a current evidence of alcohol abuse.
Subject with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens .
Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Initiation or increase in the dose, within the past 7 days or scheduled during the study, of a treatment with:
Subjects who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
Subjects who have used any investigational product within 30 days prior to enrollment.
Subjects participating in another trial at the same time.
Subject who intend to donate blood during the study or within 3 months after study completion.
Subjects in the exclusion period of the "Fichier National des Personnes qui se Prêtent à des Recherches Biomédicales" (National Index of Persons Participating in Biomedical Researches, or National Index of Volunteers).
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60 subjects who started selection were the number of subjects who attended the selection visit and signed informed consent
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| ID | Title | Description |
|---|---|---|
| FG000 | Subutex®/Suboxone® | Subutex® for first two days of study followed by Suboxone® for last 3 days of study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Selection |
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| buprenorphine/naloxone | Drug | 2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment (Days 1 Through 5) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subutex®/Suboxone® | Subutex® for first two days of study followed by Suboxone® for last 3 days of study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). | Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied" | Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit. | Posted | Mean | Standard Deviation | centimeters | Each treatment Day (post-dose on days 1-5) |
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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 | Subutex®/Suboxone® | Subutex® for first two days of study followed by Suboxone® for last 3 days of study | 0 | 53 | 8 | 53 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (9.1) |
| ||
| Headache | Nervous system disorders | MedDRA (9.1) |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) |
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The sponsor agreement is always necessary before PI publishing or communications. The sponsor can review the communication project during 28 days. The sponsor can require changes to the communication and can extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Clinical Trials Registry and Results Disclosure Group | Schering-Plough | ClinicalTrialsDisclosure@spcorp.com |
| 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 |
|---|---|
| D002047 | Buprenorphine |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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