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Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

NCT02372578•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has a BMI ≤ 40.
•Subject has all of the following:
•1. Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.
•2. Stable diabetic drug regimen for at least 3 months prior to Screening.
•3. At least a 1 year history of PDPN.
•4. Diagnosis of PDPN to be confirmed by a score of ≥ 3 on the Michigan Neuropathy Screening Instrument (MNSI) at Screening.
•Subject has pain intensity score(s) ≥ 4 or ≤ 9 on an 11-point numeric pain rating scale (NPRS) at Screening Visit and prior to Randomization.
•Subject agrees to complete pain diaries and is complaint with the daily pain recording prior to Randomization as defined by the completion of a minimum of 5 of 7 daily pain ratings, 3 of which are required in the last 4 days.
•Subject's anti-diabetic regimen is anticipated to be stable throughout the study.
•Subject must be willing to washout of all medications currently being taken for his/her PDPN (chronic and occasional/as needed) and remain off of those pain medications while participating in the study.

Exclusion Criteria

•Subject has received prior treatment with pregabalin for PDPN and was considered unresponsive or intolerant.
•Subject has tried and failed 3 or more drugs to treat PDPN within the past 3 years. Drugs must have been administered at therapeutic doses and have been administered for an adequate period of time.
•Subject has a known hypersensitivity to ASP3662, pregabalin, gabapentin or acetaminophen, or their formulation components.
•Subject has significant pain (moderate or above) due to causes other than PDPN.
•Subject has a history of painful peripheral neuropathy due to a cause other than diabetes.
•Subject has any lower extremity amputation
•Subject has a current or previous foot ulcer within the past 3 months as described by medical history and/or medical examination.
•Subject has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years.
•Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine at Screening.
•Subject has creatinine clearance \< 60 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation) at Screening.
+4 more criteria

Locations (37)

Site US10001

Anniston, Alabama, United States

Site US10039

Phoenix, Arizona, United States

Site US10054

Fresno, California, United States

Site US10020

Lomita, California, United States

Site US10047

Santa Monica, California, United States

Site US10017

Tustin, California, United States

Site US10055

Walnut Creek, California, United States

Site US10053

Fairfield, Connecticut, United States

Site US10005

Boynton Beach, Florida, United States

Site US10023

Bradenton, Florida, United States

Key Dates

Start Date

May 27, 2015

Primary Completion Date

May 20, 2016

Completion Date

May 20, 2016

Last Updated

March 26, 2019

Enrollment

115

ACTUAL participants

Conditions

Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions

ASP3662

DRUG

pregabalin

DRUG

ASP3662 placebo

DRUG

pregabalin placebo

DRUG

A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

NCT01478607

Painful Diabetic Peripheral Neuropathy (PDPN)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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