Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects with Painful Diabetic Peripheral Neuropathy, Trial ID 3662-CL-0049

Study 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).

Additional Study Details

Phase

Product

N/A

Product

ASP3662

pregabalin

ASP3662 placebo

pregabalin placebo

Type

Interventional

Masking

Triple (Participant, Investigator, Outcomes Assessor)

Enrollment number

115

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Study documents

Scientific Results Summary

Available Language(s): English

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Plain Language Summary

Available Language(s): English

Download Document(s)

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Would you like more information about clinical trial sites that are recruiting participants for Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects with Painful Diabetic Peripheral Neuropathy? Contact us by filling out your information to the right and we’ll respond to you.

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Locations

Terminated

Site US10064

Metairie, LA, United States, 70006

Terminated

Site US10036

Chicago, IL, United States, 60624

Terminated

Site US10013

Kettering, OH, United States, 45429

Terminated

Site US10063

Quincy, MA, United States, 02169

Terminated

Site US10014

Duncansville, PA, United States, 16635

Terminated

Site US10043

Hazelwood, MO, United States, 63042

Terminated

Site US10047

Santa Monica, CA, United States, 90404

Terminated

Site US10051

Boston, MA, United States, 02115

Terminated

Site US10003

Oviedo, FL, United States, 32765

Terminated

Site US10005

Boynton Beach, FL, United States, 33436

Withdrawn

Site US10030

Medford, OR, United States, 97504

Terminated

Site US10031

San Antonio, TX, United States, 78228

Terminated

Site US10009

Aurora, IL, United States, 60506

Terminated

Site US10039

Phoenix, AZ, United States, 85023

Terminated

Site US10033

Salt Lake City, UT, United States, 84107

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Site US10049

The Villages, FL, United States, 32162

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Site US10018

Clearwater, FL, United States, 33765

Terminated

Site US10046

Orlando, FL, United States, 32806

Terminated

Site US10001

Anniston, AL, United States, 36207

Terminated

Site US10025

Evansville, IN, United States, 47714

Terminated

Site US10026

New Bedford, MA, United States, 02740-2133

Terminated

Site US10020

Lomita, CA, United States, 90717

Terminated

Site US10019

Deland, FL, United States, 32720

Terminated

Site US10008

Ormond Beach, FL, United States, 32174

Terminated

Site US10054

Fresno, CA, United States, 93720

Terminated

Site US10041

MiamiLakes, FL, United States, 33014

Withdrawn

Site US10027

Pasadena, MD, United States, 21122

Terminated

Site US10004

Homestead, FL, United States, 33030

Terminated

Site US10053

Fairfield, CT, United States, 06824

Terminated

Site US10023

Bradenton, FL, United States, 34205

Terminated

Site US10032

San Antonio, TX, United States, 78218

Terminated

Site US10042

Jacksonville, FL, United States, 32256

Terminated

Site US10045

Renton, WA, United States, 98057

Terminated

Site US10034

Austin, TX, United States, 78731

Terminated

Site US10017

Tustin, CA, United States, 92780

Terminated

Site US10007

Jupiter, FL, United States, 33458

Terminated

Site US10055

Walnut Creek, CA, United States, 94598

Terminated

Site US10015

Greer, SC, United States, 29651

Terminated

Site US10040

Houston, TX, United States, 77030

Trial info

Follow Trial

Age

18 - 75 years

Condition

Neuropathic Pain

Sex

Female & Male

Trial Dates

May 2015 - May 2016

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Additional Study Details

Inclusion Criteria

Subject has a BMI ≤ 40.
Subject has all of the following:

a. Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.

b. Stable diabetic drug regimen for at least 3 months prior to Screening.

c. At least a 1 year history of PDPN.

d. 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.
Subject tests positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody at Screening or has a known history of a positive test for human immunodeficiency virus (HIV) infection.
Subject has a positive drug screen for alcohol or drugs of abuse at Screening and/or Randomization. Subjects who are on low doses of benzodiazepines for sleep with a legitimate prescription will be allowed into the study. In addition, subjects with a positive drug screen at Randomization will be

excluded.

Subject is currently using protocol specified non-permitted medications including OTC products and is unable or does not choose to discontinue them.
Subject has planned an elective surgery during planned study participation.

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

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