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

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Diabetic Neuropathies; Pain

Treatments: Drug: Placebo; Drug: DVS SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00283842

3151A5-322

Details and patient eligibility

About

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.

Enrollment: 408 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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408 participants in 5 patient groups, including a placebo group

desvenlafaxine succinate sustained-release (DVS SR) 50mg

Experimental group

Treatment:

Drug: DVS SR

desvenlafaxine succinate sustained-release (DVS SR) 100mg

Experimental group

Treatment:

Drug: DVS SR

desvenlafaxine succinate sustained-release (DVS SR) 200mg

Experimental group

Treatment:

Drug: DVS SR

desvenlafaxine succinate sustained-release (DVS SR) 400mg

Experimental group

Treatment:

Drug: DVS SR

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo