Clinical trial NCT00283842: Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Neuropathies
Pain
Keywords: neuropathic pain
diabetic peripheral neuropathy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 408
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: The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Diabetes type 1 or 2
* Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months

Exclusion Criteria:

* Major Depression
* Uncontrolled diabetes

Primary outcomes:
measure: Change in Mean Pain Severity Score From Baseline to 13 Weeks
timeFrame: Baseline and 13 weeks
Secondary outcomes:
measure: Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
timeFrame: Baseline and 13 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Encino
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Pueblo
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: Stratford
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Ft. Myers
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Coeur D'Alene
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Madisonville
country: United States
state: Kentucky
city: Springfield
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Albany
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Collegeville
country: United States
state: Pennsylvania
city: Feasterville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Allen R, Sharma U, Barlas S. Clinical experience with desvenlafaxine in treatment of pain associated with diabetic peripheral neuropathy. J Pain Res. 2014 Jun 23;7:339-51. doi: 10.2147/JPR.S55682. eCollection 2014.