Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01426230 |
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Recruitment Status :
Completed
First Posted : August 31, 2011
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
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Sponsor:
Depomed
Information provided by (Responsible Party):
Depomed
- Study Details
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- Study Results
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Brief Summary:
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
| Condition or disease |
|---|
| Post Herpetic Neuralgia |
| Study Type : | Observational |
| Actual Enrollment : | 201 participants |
| Time Perspective: | Prospective |
| Official Title: | A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | April 2012 |
| Group/Cohort |
|---|
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Open Label
Cohort by age- - Patients >70 Yrs old |
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Open label
Cohort by age- - Patients < 70 Yrs old |
Primary Outcome Measures :
- Change From Baseline to End of Study in LOCF VAS [ Time Frame: 8 weeks (Baseline and Week 8) ]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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients currently suffering from Post Herpetic Neuralgia
Criteria
Inclusion Criteria:
- Men or Women 18 years or older who are suffering from PHN
Exclusion Criteria:
- Patient is Pregnant or a nursing mother
- Patient has hypersensitivity to gabapentin
- Patient has an estimated creatinine clearance of <30 mL/min or is in hemodialysis
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426230
Locations
| United States, Alabama | |
| Mobile, Alabama, United States | |
| Tuscaloosa, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Sun City, Arizona, United States | |
| Tucson, Arizona, United States | |
| United States, California | |
| Fresno, California, United States | |
| San Francisco, California, United States | |
| United States, Connecticut | |
| Fairfield, Connecticut, United States | |
| United States, Florida | |
| 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 | |
| United States, Georgia | |
| Marietta, Georgia, United States | |
| United States, Illinois | |
| Bolingbrook, Illinois, United States | |
| United States, Indiana | |
| Evansville, Indiana, United States | |
| United States, Kentucky | |
| Lexington, Kentucky, United States | |
| United States, Massachusetts | |
| Brighton, Massachusetts, United States | |
| Worcestor, Massachusetts, United States | |
| United States, Missouri | |
| Jefferson City, Missouri, United States | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Tom River, New Jersey, United States | |
| United States, North Carolina | |
| Hickory, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| United States, Pennsylvania | |
| Allentown, Pennsylvania, United States | |
| Altoona, Pennsylvania, United States | |
| Wyomissing, Pennsylvania, United States | |
| United States, South Carolina | |
| Mt. Pleasant, South Carolina, United States | |
| United States, Tennessee | |
| Cordova, Tennessee, United States | |
| United States, Texas | |
| Austin, Texas, United States | |
| Bedford, Texas, United States | |
| Corpus Christi, Texas, United States | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Orem, Utah, United States | |
| United States, Washington | |
| Edmonds, Washington, United States | |
Sponsors and Collaborators
Depomed
Investigators
| Study Director: | Rekha Sathyanarayana | Depomed Clinical Operations |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Depomed |
| ClinicalTrials.gov Identifier: | NCT01426230 |
| Other Study ID Numbers: |
81-0067 |
| First Posted: | August 31, 2011 Key Record Dates |
| Results First Posted: | March 21, 2013 |
| Last Update Posted: | March 21, 2013 |
| Last Verified: | March 2013 |
Keywords provided by Depomed:
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PHN Post Herpetic Neuralgia Shingles HZ roster |
Additional relevant MeSH terms:
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Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |