[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

• ClinicalTrials.gov Identifier: NCT00354094
• Recruitment Status: Terminated
• First Posted: July 20, 2006
• Last Update Posted: November 8, 2007
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: July 18, 2006
• First Posted Date: July 20, 2006
• Last Update Posted Date: November 8, 2007
• Study Start Date: November 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: July 18, 2006)

• Vital signs
• Physical examination
• 12-lead ECG
• Hematology/Biochemistry
• Adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 18, 2006)

• Pain Visual Analogue Scale
• Patient Global Impression of Change
• Neuropathic Pain Symptom Inventory
• Modified Brief Pain Inventory - Short Form
• SF-12 Health Survey
• EQ-5D
• Analgesic Treatment Satisfaction Scale
• Pain-related Medication Utilization

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: [S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
• 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).
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain
• Intervention: Drug: [S,S]-Reboxetine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: July 18, 2006): 600
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Canada, Chile, Croatia, India, Lithuania, Mexico, Poland, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT00354094
• Other Study ID Numbers: A6061030
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2007