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

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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
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 |
neuropathic pain diabetic peripheral neuropathy |
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |