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Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00283842
Recruitment Status : Terminated (business reasons)
First Posted : January 30, 2006
Results First Posted : August 13, 2009
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Pain Drug: DVS SR Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: desvenlafaxine succinate sustained-release (DVS SR) 50mg Drug: DVS SR
Experimental: desvenlafaxine succinate sustained-release (DVS SR) 100mg Drug: DVS SR
Experimental: desvenlafaxine succinate sustained-release (DVS SR) 200mg Drug: DVS SR
Experimental: desvenlafaxine succinate sustained-release (DVS SR) 400mg Drug: DVS SR
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in Mean Pain Severity Score From Baseline to 13 Weeks [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. Number of Patients With ≥50% Reduction in Mean Pain Severity Score. [ Time Frame: Baseline and 13 weeks ]
    Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283842


Locations
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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00283842    
Other Study ID Numbers: 3151A5-322
First Posted: January 30, 2006    Key Record Dates
Results First Posted: August 13, 2009
Last Update Posted: October 24, 2011
Last Verified: October 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
neuropathic pain
diabetic peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases