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

October 20, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
      • Peoria, Arizona, United States, 85381
      • Phoenix, Arizona, United States, 85016
    • California
      • Encino, California, United States, 91316
      • Newport Beach, California, United States, 92660
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Pueblo, Colorado, United States, 81001
    • Connecticut
      • New Britain, Connecticut, United States, 06050
      • Stratford, Connecticut, United States, 06615
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Ft. Myers, Florida, United States, 33907
      • Palm Beach Gardens, Florida, United States, 33418
      • Pembroke Pines, Florida, United States, 33026
      • St. Petersburg, Florida, United States, 33709
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
      • Roswell, Georgia, United States, 30076
    • Idaho
      • Coeur D'Alene, Idaho, United States, 83814
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • St. Louis, Missouri, United States, 63141
      • St. Louis, Missouri, United States, 63117
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Omaha, Nebraska, United States, 88131
    • New York
      • Albany, New York, United States, 12205
      • Flushing, New York, United States, 11365
      • New York, New York, United States, 10024
      • Rochester, New York, United States, 14621
      • Staten Island, New York, United States, 10312
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Cincinnati, Ohio, United States, 45236
      • Dayton, Ohio, United States, 45432
      • Toledo, Ohio, United States, 43623
    • Pennsylvania
      • Collegeville, Pennsylvania, United States, 19426
      • Feasterville, Pennsylvania, United States, 19053
      • Harleysville, Pennsylvania, United States, 19438
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75246
      • San Antonio, Texas, United States, 78229
    • Utah
      • Midvale, Utah, United States, 84047
      • Salt Lake City, Utah, United States, 84106
    • Virginia
      • Virginia Beach, Virginia, United States, 23451
    • Washington
      • Lakewood, Washington, United States, 98499
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 20, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A5-322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe