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A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

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NCT00625833

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 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.
Diabetic Neuropathies
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

- Male or female of any race at least 18 years of age

- Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due
to diabetes, for at least 1 year

- Patients at Visit 1 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

- Neurological disorders unrelated to diabetic neuropathy that may confuse the
assessment of neuropathic pain

- Any pain or other condition that may confound assessment or self-evaluation of the
pain due to diabetic neuropathy

- Amputations other than toes

- A current or recent diagnosis (past 6 months) or episode of major depressive disorder
and/or uncontrolled depression

- History of transient ischemic attack or stroke

- Myocardial infarction or unstable angina within the past three months

NCT00625833
Pfizer
Terminated
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

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A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathies
  • Drug: Placebo
    Oral tablet once a day dosing for 10 weeks.
  • Drug: [S,S]-Reboxetine
    Oral tablet once a day dosing for 10 weeks.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: [S,S]-Reboxetine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
330
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female of any race at least 18 years of age
  • Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
  • Patients at Visit 1 must have a score ?40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

  • Patients with significant hepatic impairment
  • Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
  • Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
  • Amputations other than toes
  • A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
  • History of transient ischemic attack or stroke
  • Myocardial infarction or unstable angina within the past three months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Finland,   Netherlands,   South Africa,   Spain,   United States
 
 
NCT00625833
A6061037
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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