Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
This study has been terminated.
(business reasons)
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00283842
First received: January 26, 2006
Last updated: October 20, 2011
Last verified: October 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathies Pain |
Drug: DVS SR Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Change in Mean Pain Severity Score From Baseline to 13 Weeks [ Time Frame: Baseline and 13 weeks ] [ Designated as safety issue: No ]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:
- Number of Patients With ≥50% Reduction in Mean Pain Severity Score. [ Time Frame: Baseline and 13 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 408 |
| Study Start Date: | March 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283842
Show 51 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283842
Show 51 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00283842 History of Changes |
| Other Study ID Numbers: | 3151A5-322 |
| Study First Received: | January 26, 2006 |
| Results First Received: | June 30, 2009 |
| Last Updated: | October 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
neuropathic pain diabetic peripheral neuropathy |
Additional relevant MeSH terms:
|
Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Desvenlafaxine Succinate |
Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on September 28, 2016