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:

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Desvenlafaxine Desvenlafaxine Succinate

U.S. FDA Resources

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 ]
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 ]
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)
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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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

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 June 22, 2017

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