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Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Cohort by age- - Patients >70 Yrs old | ||
| Open label | Cohort by age- - Patients < 70 Yrs old |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in LOCF VAS | Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis | 8 weeks (Baseline and Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients currently suffering from Post Herpetic Neuralgia
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| Name | Affiliation | Role |
|---|---|---|
| Rekha Sathyanarayana | Depomed Clinical Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27037091 | Derived | Mehta N, Bucior I, Bujanover S, Shah R, Gulati A. Relationship between pain relief, reduction in pain-associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended-release gabapentin. Health Qual Life Outcomes. 2016 Apr 1;14:54. doi: 10.1186/s12955-016-0456-0. |
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201 patients were enrolled, but only 197 patients received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label - Cohort >70 Yrs Old | Cohort by age- - Patients >70 Yrs old |
| FG001 | Open Label - Cohort <=70 Yrs Old | Cohort by age- - Patients <=70 Yrs old |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tuscaloosa |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Sun City | Arizona | United States |
| Tucson | Arizona | United States |
| Fresno | California | United States |
| San Francisco | California | United States |
| Fairfield | Connecticut | United States |
| Lauderdale Lakes | Florida | United States |
| Naples | Florida | United States |
| North Palm Beach | Florida | United States |
| Ormond Beach | Florida | United States |
| Palm Beach | Florida | United States |
| Sunrise | Florida | United States |
| Marietta | Georgia | United States |
| Bolingbrook | Illinois | United States |
| Evansville | Indiana | United States |
| Lexington | Kentucky | United States |
| Brighton | Massachusetts | United States |
| Worcestor | Massachusetts | United States |
| Jefferson City | Missouri | United States |
| St Louis | Missouri | United States |
| Tom River | New Jersey | United States |
| Hickory | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Allentown | Pennsylvania | United States |
| Altoona | Pennsylvania | United States |
| Wyomissing | Pennsylvania | United States |
| Mt. Pleasant | South Carolina | United States |
| Cordova | Tennessee | United States |
| Austin | Texas | United States |
| Bedford | Texas | United States |
| Corpus Christi | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Orem | Utah | United States |
| Edmonds | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label - Cohort >70 Yrs Old | Cohort by age- - Patients >70 Yrs old |
| BG001 | Open Label - Cohort <=70 Yrs Old | Cohort by age- - Patients <=70 Yrs old |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change From Baseline to End of Study in LOCF VAS | Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis | The Number of Participants Analyzed was based on the available VAS. | Posted | Mean | 95% Confidence Interval | scores on a scale | 8 weeks (Baseline and Week 8) |
|
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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 | Open Label - Both Cohorts | 5 | 197 | 38 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders |
| |||
| Duodenal ulcer | Gastrointestinal disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Gout | Metabolism and nutrition disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Haematuria | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
| |||
| Somnolence | Nervous system disorders |
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Restriction Description: The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | Depomed | 510-744-8000 | msweeney@depomed.com |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| 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 |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| >=65 years |
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| Male |
|