Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 435 for:    B-49

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

This study has been terminated.
(The study was stopped due to business/operational issues.)
Information provided by:
Pfizer Identifier:
First received: July 18, 2006
Last updated: November 7, 2007
Last verified: November 2007

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.

Condition Intervention Phase
Drug: [S,S]-Reboxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Vital signs
  • Physical examination
  • 12-lead ECG
  • Hematology/Biochemistry
  • Adverse events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 600
Study Start Date: November 2006
Study Completion Date: October 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00354094

  Show 40 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided Identifier: NCT00354094     History of Changes
Other Study ID Numbers: A6061030
Study First Received: July 18, 2006
Last Updated: November 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on March 03, 2015