Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2007-12-19
2009-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
RN624
50 mcg/kg
2
RN624
200 mcg/kg
3
Placebo
placebo
Interventions
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RN624
50 mcg/kg
RN624
200 mcg/kg
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
* Has a pain score at screening that qualifies.
* Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
* Body Mass Index less than or equal to 39 kg/m2.
* If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
* Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
* Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Patients must consent in writing to participate in the study.
Exclusion Criteria
* Disqualifying scores on questionnaires.
* Other moderate to severe pain from other conditions.
* History of allergic or anaphylactic reaction to antibodies.
* Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
* Unable to use acetaminophen.
* Disqualify laboratory values, Hepatitis B or C or HIV.
* Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
* Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
* Cancer other than basal cell or squamous cell carcinoma.
* Fails a urine test for illegal drugs including prescription drugs without a prescription.
* Plans for surgery during the study.
* History of alcoholism or drug abuse in the past two years.
* Surgery for post-herpetic neuralgia.
* Any condition that the investigator feels would put the safety of the patient at risk.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anniston Medical Clinic/Pinnacle Research Group LLC
Anniston, Alabama, United States
Anniston Neurology & Headache Mgmt. Ctr.
Anniston, Alabama, United States
Dedicated Clinical Research, Inc.
Litchfield Park, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Jem Research, LLC
Atlantis, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Innovative Research of West Florida, Inc.
Largo, Florida, United States
Miami Medical Associates
Miami, Florida, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
Meridien Research
Tampa, Florida, United States
Cotton-O'Neil Clinical Research
Topeka, Kansas, United States
Cotton-O'Neil Clinic
Topeka, Kansas, United States
International Research Center
Towson, Maryland, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States
A & A Pain Institute
St Louis, Missouri, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
DiscoveResearch Incorporated
Bryan, Texas, United States
Neurological Clinic of Texas
Dallas, Texas, United States
Mobley Research Center
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Jay Ellis Jr., MD-Tejas Anesthesia
San Antonio, Texas, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, United States
National Clinical Research, Incorporated
Richmond, Virginia, United States
Countries
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References
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Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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PHN POC
Identifier Type: OTHER
Identifier Source: secondary_id
A4091005
Identifier Type: -
Identifier Source: org_study_id
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