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

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NCT00625833

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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
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Contact
1-800-718-1021
[email protected]
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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Official Title  ICMJE A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Brief Summary 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.
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 Diabetic Neuropathies
Intervention  ICMJE
  • Drug: Placebo
    Oral tablet once a day dosing for 10 weeks.
  • Drug: [S,S]-Reboxetine
    Oral tablet once a day dosing for 10 weeks.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: [S,S]-Reboxetine
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: February 19, 2008)		330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Czechia,   Finland,   Netherlands,   South Africa,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00625833
Other Study ID Numbers  ICMJE A6061037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
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