TerminatedPhase 2

Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

Stopped: The study was terminated due to futility analysis.

United States115 participantsStarted 2015-05-27

Plain-language summary

The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo. The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.
✓. Stable diabetic drug regimen for at least 3 months prior to Screening.
✓. At least a 1 year history of PDPN.
✓. Diagnosis of PDPN to be confirmed by a score of ≥ 3 on the Michigan Neuropathy Screening Instrument (MNSI) at Screening.

What they're measuring

Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS

Timeframe: Baseline to Week 6/ End of Treatment (EOT)

Trial details

NCT IDNCT02372578

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05-20

View on ClinicalTrials.gov More Painful Diabetic Peripheral Neuropathy (PDPN) trials