Pain Clinical Trial
Official title:
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).
| Verified date | November 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.
| Status | Terminated |
| Enrollment | 600 |
| Est. completion date | October 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Sudbury | Ontario |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Chile | Pfizer Investigational Site | Santiago | RM |
| Chile | Pfizer Investigational Site | Viña del Mar | V Región |
| Croatia | Pfizer Investigational Site | Split | |
| India | Pfizer Investigational Site | Bangalore | |
| India | Pfizer Investigational Site | Chandigarh | Punjab |
| India | Pfizer Investigational Site | Chennai | |
| India | Pfizer Investigational Site | Hyderabad | |
| India | Pfizer Investigational Site | Hyderabad | Andhra Pradhesh |
| India | Pfizer Investigational Site | New Delhi | |
| India | Pfizer Investigational Site | New Delhi | |
| Lithuania | Pfizer Investigational Site | Kaunas | |
| Lithuania | Pfizer Investigational Site | Klaipeda | |
| Lithuania | Pfizer Investigational Site | Panevezys | |
| Lithuania | Pfizer Investigational Site | Siauliai | |
| Mexico | Pfizer Investigational Site | Merida | Yucatan |
| Poland | Pfizer Investigational Site | Sopot | |
| Spain | Pfizer Investigational Site | Ourense | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| United Kingdom | Pfizer Investigational Site | Addlestone | Surrey |
| United Kingdom | Pfizer Investigational Site | Alcester | |
| United Kingdom | Pfizer Investigational Site | Bexhill on Sea | East Sussex |
| United Kingdom | Pfizer Investigational Site | East Sussex | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United States | Pfizer Investigational Site | Cumberland | Rhode Island |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Greensboro | North Carolina |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Canada, Chile, Croatia, India, Lithuania, Mexico, Poland, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vital signs | |||
| Primary | Physical examination | |||
| Primary | 12-lead ECG | |||
| Primary | Hematology/Biochemistry | |||
| Primary | Adverse events | |||
| Secondary | Pain Visual Analogue Scale | |||
| Secondary | Patient Global Impression of Change | |||
| Secondary | Neuropathic Pain Symptom Inventory | |||
| Secondary | Modified Brief Pain Inventory - Short Form | |||
| Secondary | SF-12 Health Survey | |||
| Secondary | EQ-5D | |||
| Secondary | Analgesic Treatment Satisfaction Scale | |||
| Secondary | Pain-related Medication Utilization |
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