RN624 For Pain Of Post-Herpetic Neuralgia

Pfizer

Status and phase

Completed

Phase 2

Conditions

Neuralgia, Postherpetic

Treatments

Drug: RN624

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00568321

PHN POC (Other Identifier)

A4091005

Details and patient eligibility

About

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).

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.