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RN624 For Pain Of Post-Herpetic Neuralgia

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postherpetic Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00568321
Pfizer
Completed
RN624 For Pain Of Post-Herpetic Neuralgia

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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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuralgia, Postherpetic
  • Drug: RN624
    50 mcg/kg
  • Drug: RN624
    200 mcg/kg
  • Drug: Placebo
    placebo
  • Experimental: 1
    Intervention: Drug: RN624
  • Active Comparator: 2
    Intervention: Drug: RN624
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00568321
A4091005
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

Contact

[email protected]



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