RN624 For Pain Of Post-Herpetic Neuralgia

Completed · Phase 2 · Has a placebo group

Conditions studied: Neuralgia, Postherpetic

In brief

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).

Key facts

Study ID

NCT00568321

Run by

Pfizer

People needed

99

Starts

2007-12-19

Expected to finish

2009-01-07

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female of any race, at least 18 years of age.
• 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.

You may not qualify if…

• Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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