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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00568321 |
Purpose
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgia, Postherpetic |
Drug: RN624 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Proof Of Concept Study Of The Analgesic Effects Of RN624 In Adult Patients With Post-Herpetic Neuralgia |
| Enrollment: | 99 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: RN624
50 mcg/kg
|
| 2: Active Comparator |
Drug: RN624
200 mcg/kg
|
| 3: Placebo Comparator |
Drug: Placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Anniston, Alabama, United States, 36207 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Litchfield Park, Arizona, United States, 85340 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85023 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Sunrise, Florida, United States, 33351 | |
| Pfizer Investigational Site | |
| Clearwater, Florida, United States, 33765 | |
| Pfizer Investigational Site | |
| Largo, Florida, United States, 33770 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| Pfizer Investigational Site | |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Pfizer Investigational Site | |
| Atlantis, Florida, United States, 33462 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33175 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Towson, Maryland, United States, 21286 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| N. Dartmouth, Massachusetts, United States, 02747 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Edina, Minnesota, United States, 55435 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St Louis, Missouri, United States, 63141 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Asheville, North Carolina, United States, 28806 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45432 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44122 | |
| Pfizer Investigational Site | |
| Kettering, Ohio, United States, 45429 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635-0909 | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| Bryan, Texas, United States, 77802 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A4091005 |
| Study First Received: | December 3, 2007 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00568321 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
monoclonal antibody |
|
Neuralgia, Postherpetic Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain |