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RN624 For Pain Of Post-Herpetic Neuralgia
This study has been completed.
Study NCT00568321   Information provided by Pfizer
First Received: December 3, 2007   Last Updated: October 21, 2009   History of Changes

December 3, 2007
October 21, 2009
November 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00568321 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
 
RN624 For Pain Of Post-Herpetic Neuralgia
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

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).

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Neuralgia, Postherpetic
  • Drug: RN624
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
99
January 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00568321
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A4091005
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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