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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00354094 |
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Date of registration:
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18/07/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
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Scientific title:
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A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN). |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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600 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00354094 |
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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: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Canada
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Chile
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Croatia
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India
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Lithuania
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Mexico
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Poland
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Spain
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Sweden
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United Kingdom
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United States
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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 healing of the shingles
skin rash.
- Patients at screening must have a score of >/=40mm on the pain visual analogue scale.
Exclusion Criteria:
- Patients with significant hepatic impairment.
- Patients with other severe pain, that may impair the self-assessment of pain due to
postherpetic neuralgia (pain after shingles).
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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Physical examination
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Adverse events
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Hematology/Biochemistry
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12-lead ECG
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Vital signs
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Secondary Outcome(s)
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SF-12 Health Survey
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EQ-5D
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Modified Brief Pain Inventory - Short Form
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Neuropathic Pain Symptom Inventory
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Analgesic Treatment Satisfaction Scale
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Patient Global Impression of Change
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Pain-related Medication Utilization
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Pain Visual Analogue Scale
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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