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

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
Tampa, Florida, 33606 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00354094
Pfizer
Terminated
[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: July 18, 2006)
600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Croatia,   India,   Lithuania,   Mexico,   Poland,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354094
Other Study ID Numbers  ICMJE A6061030
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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