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This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.
Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual administration | Experimental | Buprenorphine/naloxone film strip administered sublingually |
|
| Buccal administration | Experimental | Buprenorphine/naloxone film strip administered buccally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone Film Strip | Drug | Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs | 12 weeks |
| Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. | 12 weeks |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subjects must not:
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| Name | Affiliation | Role |
|---|---|---|
| Donald R. Jasinski, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Winston Technology Research LLC |
Subjects were required to be on a stabilized dose of buprenorphine and naloxone for at least 30 days prior to study drug administration, either during the screening period, or as part of routine medical treatment during the previous 30 days.
Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine/Naloxone Film Strip Administered Sublingually | |
| FG001 | Buprenorphine/Naloxone Film Strip Administered Buccally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine/Naloxone Film Strip Administered Sublingually | |
| BG001 | Buprenorphine/Naloxone Film Strip Administered Buccally | |
| BG002 | Total |
| 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 | Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs | The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed. | Posted | Dec 2009 | Number | Participants | 12 weeks |
|
12 weeks
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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 | Buprenorphine/Naloxone Film Strip Administered Sublingually |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral mucosal erythema | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs | Reckitt Benckiser Pharmaceuticals, Inc. | 804-379-1090 | 7089 | ed.johnson@reckittbenckiser.com |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Buprenorphine/naloxone Film Strip | Drug | Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route |
|
| Haleyville |
| Alabama |
| 35565 |
| United States |
| Beeches Family Medicine | Jacksonville Beach | Florida | 32250 | United States |
| Physician Decision |
|
| Sponsor's Decision |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Other Reason |
|
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age Categorical | The age categories used for this study were slightly different than the standard values and are reflected as reported in the study. | Number | Participants |
|
| Severity Grading of Oral Mucosa | Safety and tolerability were evaluated at baseline by oral cavity examination. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs | Number | Participants |
|
| Buprenorphine/Naloxone Film Strip Administered Buccally |
|
|
| Primary | Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. | The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed. | Posted | Number | Participants | 12 weeks |
|
|
|
| 4 |
| 194 |
| 11 |
| 194 |
| EG001 | Buprenorphine/Naloxone Film Strip Administered Buccally | 2 | 188 | 16 | 188 |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
| 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 |
| Severe |
|