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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)

NCT02215252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2017-05-05

Study results available
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Summary

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)

Conditions

  • Diabetic Neuropathy, Painful

Interventions

DRUG

PF-05089771 150 mg

PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

DRUG

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

Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

DRUG

Pregabalin 300 mg

Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

DRUG

PF-05089771 150 mg + Pregabalin 300 mg

PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-10
Primary Completion
2015-07-15
Completion
2015-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02215252 on ClinicalTrials.gov