CompletedPhase 3

Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

United States217 participantsStarted 2011-10

Plain-language summary

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men or women who are at least 18 years old. * Diagnosis of painful diabetic peripheral neuropathy. * Pain on walking. Exclusion Criteria: * Inability to walk 50 feet on a flat surface. * Pain on walking due to conditions other than diabetic peripheral neuropathy.

What they're measuring

Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

Timeframe: End of Period (includes both Visits 6 and 11)

DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)

Timeframe: End of Period (includes both Visits 6 and 11)

Trial details

NCT IDNCT01474772

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2014-05-21

View on ClinicalTrials.gov More Diabetic Peripheral Neuropathy trials