Study Stopped
business reasons
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
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
1 other identifier
interventional
408
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 13, 2009
CompletedOctober 24, 2011
October 1, 2011
2.3 years
January 26, 2006
June 30, 2009
October 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Baseline and 13 weeks
Secondary Outcomes (1)
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Baseline and 13 weeks
Study Arms (5)
desvenlafaxine succinate sustained-release (DVS SR) 50mg
EXPERIMENTALdesvenlafaxine succinate sustained-release (DVS SR) 100mg
EXPERIMENTALdesvenlafaxine succinate sustained-release (DVS SR) 200mg
EXPERIMENTALdesvenlafaxine succinate sustained-release (DVS SR) 400mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diabetes type 1 or 2
- Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
You may not qualify if:
- Major Depression
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Mesa, Arizona, 85210, United States
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Encino, California, 91316, United States
Unknown Facility
Newport Beach, California, 92660, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Pueblo, Colorado, 81001, United States
Unknown Facility
New Britain, Connecticut, 06050, United States
Unknown Facility
Stratford, Connecticut, 06615, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Fort Myers, Florida, 33907, United States
Unknown Facility
Palm Beach Gardens, Florida, 33418, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Lawrenceville, Georgia, 30045, United States
Unknown Facility
Roswell, Georgia, 30076, United States
Unknown Facility
Coeur d'Alene, Idaho, 83814, United States
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Des Moines, Iowa, 50314, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Springfield, Massachusetts, 01199, United States
Unknown Facility
Ann Arbor, Michigan, 48106, United States
Unknown Facility
Kansas City, Missouri, 64114, United States
Unknown Facility
St Louis, Missouri, 63117, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Billings, Montana, 59101, United States
Unknown Facility
Omaha, Nebraska, 88131, United States
Unknown Facility
Albany, New York, 12205, United States
Unknown Facility
Flushing, New York, 11365, United States
Unknown Facility
New York, New York, 10024, United States
Unknown Facility
Rochester, New York, 14621, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
Fargo, North Dakota, 58104, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Dayton, Ohio, 45432, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Collegeville, Pennsylvania, 19426, United States
Unknown Facility
Feasterville, Pennsylvania, 19053, United States
Unknown Facility
Harleysville, Pennsylvania, 19438, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Midvale, Utah, 84047, United States
Unknown Facility
Salt Lake City, Utah, 84106, United States
Unknown Facility
Virginia Beach, Virginia, 23451, United States
Unknown Facility
Lakewood, Washington, 98499, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
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.
PMID: 25018648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U.S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 30, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
October 24, 2011
Results First Posted
August 13, 2009
Record last verified: 2011-10