| 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 ]
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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). |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Neuralgia, Postherpetic |
- Drug: RN624
- Drug: Placebo
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| |
| |
| 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.
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| 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 |
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| Pfizer |
| October 2009 |