A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: Pregabalin 300 mg; Drug: PF-05089771 150 mg + Pregabalin 300 mg; Drug: PF-05089771 150 mg; Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02215252

B3291026

DPN NAV1.7 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

Enrollment: 141 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged 18 years to 80 years.
• Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
• Presence of ongoing pain due to DPN for at least 6 months.
• Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.

Exclusion criteria

• Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
• Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
• Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
• Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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141 participants in 4 patient groups

PF-05089771

Experimental group

Treatment:

Drug: PF-05089771 150 mg

Placebo

Experimental group

Treatment:

Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg

Pregabalin

Experimental group

Treatment:

Drug: Pregabalin 300 mg

PF-05089771 + Pregabalin

Experimental group

Treatment:

Drug: PF-05089771 150 mg + Pregabalin 300 mg