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RN624 For Pain Of Post-Herpetic Neuralgia

This study is currently recruiting participants.
Verified by Pfizer, November 2008

Sponsored by: 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

MedlinePlus related topics:   Shingles   

U.S. FDA Resources

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

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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment:   129
Study Start Date:   November 2007
Estimated Study Completion Date:   January 2009
Estimated Primary Completion Date:   November 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

Contacts
Contact: Pfizer CT.gov Call Center     1-800-718-1021    

Show 28 study locations  Show 28 Study Locations

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


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

Responsible Party:   Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:   A4091005
First Received:   December 3, 2007
Last Updated:   November 24, 2008
ClinicalTrials.gov Identifier:   NCT00568321
Health Authority:   United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody  

Study placed in the following topic categories:
Antibodies, Monoclonal
Neuralgia, Postherpetic
Signs and Symptoms
Antibodies
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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