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Did not reach enrollment goals
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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
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This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.
This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 5% + placebo patch, ER and placebo pills | Active Comparator | 5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine patch 5% | Drug | lidocaine 5% patch; 12 hours on, 12 hours off |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period | subject identifies daily pain rating during final week of each treatment period using a numeric rating scale | Daily |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs) | subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries | rating of adverse events occur at each visit |
| Safety (i.e., Number of Serious Adverse Events) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H. Dworkin, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
19 subjects were enrolled in this study however the study was terminated due to not reaching enrollment goals in a timely manner. Therefore there was no data analysis completed for this study. We do not have randomization data for these participants because the data is not available and is locked.
7-6-2006 to 9-23-2008 at the medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine 5% + Placebo Patch, ER + Placebo Pills | 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Extended-release oxycodone | Drug | extended-release oxycodone titrating schedule |
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| Placebo extended-release oxycodone pills | Drug | placebo pills with titrating schedule |
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| Placebo lidocaine patches | Drug | used with extended release oxycodone group; used with placebo pills/placebo patches |
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Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales |
| rating and review of any adverse events occurs at each visit |
| Brief Pain Inventory Interference Items | subject completes the brief pain questionaire | occurs Visit 1, 3,4,5 |
| Daily Diary Sleep Interference Ratings | Subject identifies degree of sleep interference on a daily basis | daily |
| Beck Depression Inventory | Subject completes Beck questionaire | occurs at Visit 1, 3, 4 and 5 |
| Short-form Health Survey 36 (SF-36) | Subject completes short form health survey 36 questionaire | Occurs at Visit 1, 3, 4 and 5 |
| Short-Form McGill Pain Questionnaire | Subject completes short form McGill Pain questionaire | Occurs Visit 1, 3, 4 and 5 |
| Patient Global Impression of Change Scale | Subject completes patient global impression questionaire of change scale | Occurs Visit 3, 4, 5 |
| Kurtzke Expanded Disability Status Scale | Subject completes questionaire on functional status | Occurs at Visit 1 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine 5% + Placebo Patch, ER + Placebo Pills | 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period | subject identifies daily pain rating during final week of each treatment period using a numeric rating scale | Data was not analyzed because we the data is locked and is not available. | Posted | Daily |
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| Secondary | Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs) | subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | rating of adverse events occur at each visit |
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| Secondary | Safety (i.e., Number of Serious Adverse Events) | Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | rating and review of any adverse events occurs at each visit |
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| Secondary | Brief Pain Inventory Interference Items | subject completes the brief pain questionaire | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | occurs Visit 1, 3,4,5 |
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| Secondary | Daily Diary Sleep Interference Ratings | Subject identifies degree of sleep interference on a daily basis | Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available. | Posted | daily |
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| Secondary | Beck Depression Inventory | Subject completes Beck questionaire | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | occurs at Visit 1, 3, 4 and 5 |
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| Secondary | Short-form Health Survey 36 (SF-36) | Subject completes short form health survey 36 questionaire | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | Occurs at Visit 1, 3, 4 and 5 |
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| Secondary | Short-Form McGill Pain Questionnaire | Subject completes short form McGill Pain questionaire | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | Occurs Visit 1, 3, 4 and 5 |
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| Secondary | Patient Global Impression of Change Scale | Subject completes patient global impression questionaire of change scale | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | Occurs Visit 3, 4, 5 |
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| Secondary | Kurtzke Expanded Disability Status Scale | Subject completes questionaire on functional status | Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available. | Posted | Occurs at Visit 1 |
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Adverse events were not collected.
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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 | Lidocaine Patch 5% | 5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off | 0 | 0 | 0 | 0 | ||
| EG001 | Placebo Patch | placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches | 0 | 0 | 0 | 0 | ||
| EG002 | Extended Release Oxycodone | randomized subjects given extended release oxycodone and placebo patches during this treatment period Extended-release oxycodone: extended-release oxycodone titrating schedule | 0 | 0 | 0 | 0 | ||
| EG003 | Placebo Pills | placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert H Dworkin | University of Rochester | 275-8214 | robert_dworkin@urmc.rochester.edu |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511998 | Lidoderm |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| 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 |
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placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule |
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placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group Placebo extended-release oxycodone pills: placebo pills with titrating schedule |
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