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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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12 December 2020 |
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Main ID: |
NCT00334685 |
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Date of registration:
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07/06/2006 |
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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 Add-On Trial
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Scientific title:
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[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin. |
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Date of first enrolment:
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August 22, 2006 |
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Target sample size:
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136 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00334685 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Canada
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Czech Republic
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Czechia
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Germany
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Italy
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Latvia
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Netherlands
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Norway
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Poland
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Russian Federation
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Spain
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Sweden
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Switzerland
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Ukraine
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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 the healing of shingles
skin rash
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Exclusion Criteria:
- Patients with significant renal and hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due
to shingles
- Patients with clinically abnormal electrocardiogram
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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 + Pregabalin
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Drug: Pregabalin
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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 10 will be calculated
[Time Frame: Week 10]
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Secondary Outcome(s)
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Analysis of the Medical Outcomes Study Sleep Scale
[Time Frame: Week 10]
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Analysis of the Patient Global Impression of Change
[Time Frame: Week 10]
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The mean endpoint (week 10) sleep interference score change from baseline
[Time Frame: Week 10]
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Analysis of the Neuropathic Pain Symptom Inventory
[Time Frame: Week 10]
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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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