Clinical trial NCT00625833: A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Official title: A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Neuropathies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in weekly average pain score
timeFrame: 8 weeks
Secondary outcomes:
measure: Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)
timeFrame: 8 weeks
measure: Change from baseline in weekly average sleep interference scale
timeFrame: 8 weeks
measure: Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory
timeFrame: 8 weeks
measure: Modified Brief Pain Inventory-Short Form
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Marionville
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Elizabeth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cranston
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czechia
facility: Pfizer Investigational Site
city: Ostrava
country: Czechia
facility: Pfizer Investigational Site
city: Zlin
country: Czechia
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kokkola
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Lohja
country: Finland
facility: Pfizer Investigational Site
city: Almere
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Venlo
country: Netherlands
facility: Pfizer Investigational Site
city: Worcester
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Ennerdale
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Tshwane
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Stanger
country: South Africa
facility: Pfizer Investigational Site
state: Kwa- Zulu Natal
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: KwaZulu Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: LA Coruña
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Pontevedra
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: