A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
NCT ID: NCT00625833
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
330 participants
INTERVENTIONAL
2007-12-31
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Oral tablet once a day dosing for 10 weeks.
2
[S,S]-Reboxetine
Oral tablet once a day dosing for 10 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Oral tablet once a day dosing for 10 weeks.
[S,S]-Reboxetine
Oral tablet once a day dosing for 10 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mission Viejo, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
New Britain, Connecticut, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Winter Haven, Florida, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States
Pfizer Investigational Site
Jackson, Mississippi, United States
Pfizer Investigational Site
Tupelo, Mississippi, United States
Pfizer Investigational Site
Marionville, Missouri, United States
Pfizer Investigational Site
Springfield, Missouri, United States
Pfizer Investigational Site
Elizabeth, New Jersey, United States
Pfizer Investigational Site
Hamilton, New Jersey, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Cranston, Rhode Island, United States
Pfizer Investigational Site
Cumberland, Rhode Island, United States
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States
Pfizer Investigational Site
Bartlett, Tennessee, United States
Pfizer Investigational Site
Beaumont, Texas, United States
Pfizer Investigational Site
Beaumont, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
České Budějovice, , Czechia
Pfizer Investigational Site
Ostrava, , Czechia
Pfizer Investigational Site
Zlín, , Czechia
Pfizer Investigational Site
Helsinki, , Finland
Pfizer Investigational Site
Kokkola, , Finland
Pfizer Investigational Site
Lahti, , Finland
Pfizer Investigational Site
Lohja, , Finland
Pfizer Investigational Site
Almere Stad, , Netherlands
Pfizer Investigational Site
Amsterdam, , Netherlands
Pfizer Investigational Site
Venlo, , Netherlands
Pfizer Investigational Site
Worcester, Cape Town, South Africa
Pfizer Investigational Site
Bloemfontein, Free State, South Africa
Pfizer Investigational Site
Ennerdale, Gauteng, South Africa
Pfizer Investigational Site
Pretoria, Gauteng, South Africa
Pfizer Investigational Site
Durban, KwaZulu-Natal, South Africa
Pfizer Investigational Site
KwaDukuza, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Cape Town, , South Africa
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Santiago de Compostela, LA Coruña, Spain
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Madrid, , Spain
Pfizer Investigational Site
Pontevedra, , Spain
Pfizer Investigational Site
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A6061037
Identifier Type: -
Identifier Source: org_study_id