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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00143442 |
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Date of registration:
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01/09/2005 |
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Primary sponsor: |
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Public title:
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Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
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Scientific title:
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A 5-Week, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN), Who Are Gabapentin Treatment Failures. |
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Date of first enrolment:
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December 2003 |
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Target sample size:
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184 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00143442 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have pain present for more than 3 months after the healing of shingles
skin rash.
- Patients at screening must have a score > or = 40 mm on the pain visual analogue
scale.
Exclusion Criteria:
- Patients with poor renal function.
- Patients with other severe pain, that may impair the self-assessment of the pain due
to shingles.
- Patients with abnormal electrocardiogram.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: [S,S]-Reboxetine
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Primary Outcome(s)
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The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.
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Secondary Outcome(s)
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- The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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