[S,S]-Reboxetine Add-On Trial

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NCT00334685

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 the healing of shingles skin rash

- Patients at screening must have a score >/=40 mm 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 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE [S,S]-Reboxetine Add-On Trial
Official Title  ICMJE [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.
Brief Summary The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: [S,S]-Reboxetine + Pregabalin
    [S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
  • Drug: Pregabalin
    Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
Study Arms  ICMJE
  • Experimental: [S,S]-Reboxetine + Pregabalin
    Intervention: Drug: [S,S]-Reboxetine + Pregabalin
  • Active Comparator: Pregabalin
    Intervention: Drug: Pregabalin
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
Actual Enrollment  ICMJE
 (submitted: December 12, 2019)		136
Original Enrollment  ICMJE
 (submitted: June 7, 2006)		354
Actual Study Completion Date  ICMJE October 11, 2007
Actual Primary Completion Date October 4, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Austria,   Canada,   Czechia,   Germany,   Italy,   Latvia,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00334685
Other Study ID Numbers  ICMJE A6061021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP