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

NCT ID: NCT00283842

Last Updated: 2011-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathies Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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desvenlafaxine succinate sustained-release (DVS SR) 50mg

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

desvenlafaxine succinate sustained-release (DVS SR) 100mg

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

desvenlafaxine succinate sustained-release (DVS SR) 200mg

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

desvenlafaxine succinate sustained-release (DVS SR) 400mg

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DVS SR

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Encino, California, United States

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Newport Beach, California, United States

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Walnut Creek, California, United States

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Pueblo, Colorado, United States

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New Britain, Connecticut, United States

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Stratford, Connecticut, United States

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Waterbury, Connecticut, United States

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Fort Myers, Florida, United States

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Palm Beach Gardens, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Lawrenceville, Georgia, United States

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Roswell, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Des Moines, Iowa, United States

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Madisonville, Kentucky, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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Flushing, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Collegeville, Pennsylvania, United States

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Feasterville, Pennsylvania, United States

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Harleysville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Midvale, Utah, United States

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Salt Lake City, Utah, United States

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Virginia Beach, Virginia, United States

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Lakewood, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25018648 (View on PubMed)

Other Identifiers

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3151A5-322

Identifier Type: -

Identifier Source: org_study_id