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[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

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NCT00348894

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical,
sensorimotor polyneuropathy

- 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 hepatic impairment

- Patients with other severe pain, that may impair the self-assessment of the pain due
to DPN

NCT00348894
Pfizer
Terminated
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

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[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
  • Drug: [S,S]-Reboxetine
    [S,S]-reboxetine
  • Drug: Any
    Any standard of care treatment for DPN
  • Experimental: Open Treatment
    [S,S]-reboxetine
    Intervention: Drug: [S,S]-Reboxetine
  • Standard Care
    Standard Care
    Intervention: Drug: Any
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy
  • Patients at screening must have a score >/=40 mm 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 the pain due to DPN
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Croatia,   Estonia,   Finland,   Germany,   India,   Poland,   Russian Federation,   South Africa,   Sweden,   Ukraine,   United Kingdom,   United States
 
 
NCT00348894
A6061031
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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