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Trial record 1 of 1 for:    NCT00568321
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RN624 For Pain Of Post-Herpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT00568321
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : October 23, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 3, 2007
First Posted Date  ICMJE December 6, 2007
Last Update Posted Date October 23, 2009
Study Start Date  ICMJE November 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2008)
  • Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ]
  • The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ]
  • 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 ]
  • Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ]
  • 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 ]
  • score. [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
  • 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) score. [ Time Frame: 16 weeks ]
  • 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 ]
  • Incidence of and time to withdrawal due to lack of efficacy; and usage of rescue medication will be examined. [ Time Frame: 16 weeks ]
  • Safety endpoints include adverse events, physical exams and vital signs, neurological exams, cognition testing, clinical laboratory testing and electrocardiograms. [ Time Frame: 16 weeks ]
  • The pharmacokinetics of RN624 will be analyzed and Anti-Drug Antibody [ADA]) testing will be done. [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RN624 For Pain Of Post-Herpetic Neuralgia
Official Title  ICMJE 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
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia, Postherpetic
Intervention  ICMJE
  • Drug: RN624
    50 mcg/kg
  • Drug: RN624
    200 mcg/kg
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: RN624
  • Active Comparator: 2
    Intervention: Drug: RN624
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
99
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2007)
129
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00568321
Other Study ID Numbers  ICMJE A4091005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP