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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
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:

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 ] [ 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
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
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

No publications provided

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:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
 Poisoning
Substance-Related Disorders
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013