RN624 For Pain Of Post-Herpetic Neuralgia

NCT ID: NCT00568321

Last Updated: 2021-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-19

Study Completion Date

2009-01-07

Brief Summary

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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).

Detailed Description

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Conditions

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Neuralgia, Postherpetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

RN624

Intervention Type DRUG

50 mcg/kg

2

Group Type ACTIVE_COMPARATOR

RN624

Intervention Type DRUG

200 mcg/kg

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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RN624

50 mcg/kg

Intervention Type DRUG

RN624

200 mcg/kg

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Anniston Neurology & Headache Mgmt. Ctr.

Anniston, Alabama, United States

Site Status

Dedicated Clinical Research, Inc.

Litchfield Park, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Jem Research, LLC

Atlantis, Florida, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

Innovative Research of West Florida, Inc.

Largo, Florida, United States

Site Status

Miami Medical Associates

Miami, Florida, United States

Site Status

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, United States

Site Status

Neurology Clinical Research, Inc.

Sunrise, Florida, United States

Site Status

Meridien Research

Tampa, Florida, United States

Site Status

Cotton-O'Neil Clinical Research

Topeka, Kansas, United States

Site Status

Cotton-O'Neil Clinic

Topeka, Kansas, United States

Site Status

International Research Center

Towson, Maryland, United States

Site Status

Infinity Medical Research, Inc.

North Dartmouth, Massachusetts, United States

Site Status

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Medical Advanced Pain Specialists (MAPS)

Edina, Minnesota, United States

Site Status

A & A Pain Institute

St Louis, Missouri, United States

Site Status

Asheville Neurology Specialists, PA

Asheville, North Carolina, United States

Site Status

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Site Status

Hometown Urgent Care and Research

Dayton, Ohio, United States

Site Status

Wells Institute for Health Awareness

Kettering, Ohio, United States

Site Status

Allegheny Pain Management, PC

Altoona, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

DiscoveResearch Incorporated

Bryan, Texas, United States

Site Status

Neurological Clinic of Texas

Dallas, Texas, United States

Site Status

Mobley Research Center

Houston, Texas, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Jay Ellis Jr., MD-Tejas Anesthesia

San Antonio, Texas, United States

Site Status

Radiant Research San Antonio Northeast

San Antonio, Texas, United States

Site Status

National Clinical Research, Incorporated

Richmond, Virginia, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 25594611 (View on PubMed)

Related Links

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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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