ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 99 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |