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

Primary Purpose

Diabetic Neuropathies, Pain

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DVS SR
Placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring neuropathic pain, diabetic peripheral neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

desvenlafaxine succinate sustained-release (DVS SR) 50mg

desvenlafaxine succinate sustained-release (DVS SR) 100mg

desvenlafaxine succinate sustained-release (DVS SR) 200mg

desvenlafaxine succinate sustained-release (DVS SR) 400mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Mean Pain Severity Score From Baseline to 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.
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.

Full Information

First Posted
January 26, 2006
Last Updated
October 20, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00283842
Brief Title
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
business reasons
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Pain
Keywords
neuropathic pain, diabetic peripheral neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desvenlafaxine succinate sustained-release (DVS SR) 50mg
Arm Type
Experimental
Arm Title
desvenlafaxine succinate sustained-release (DVS SR) 100mg
Arm Type
Experimental
Arm Title
desvenlafaxine succinate sustained-release (DVS SR) 200mg
Arm Type
Experimental
Arm Title
desvenlafaxine succinate sustained-release (DVS SR) 400mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DVS SR
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Description
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.
Time Frame
Baseline and 13 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Description
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.
Time Frame
Baseline and 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
Country
United States
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06615
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Coeur D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
88131
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11365
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25018648
Citation
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.
Results Reference
derived

Learn more about this trial

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

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