RN624 For Pain Of Post-Herpetic Neuralgia - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Shingles

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is the change from Baseline to Week 6 in average daily pain as measured by an 11-point Numeric Rating Scale (NRS) derived from the patient daily diary. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary endpoints will examine change from Baseline for various domains of pain, and pain interference with function, using the modified Brief Pain Inventory-short form and various definitions of responder status based on the patient daily diary. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Other secondary endpoints will examine change from Baseline in the Patient's Global Assessment of Pain from Post-herpetic Neuralgia (disease activity) score and the Patient's Global Evaluation of Study Medication (treatment response) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568321

Show 27 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Pfizer:

monoclonal antibody

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on November 03, 2009