Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
NCT ID: NCT02372578
Last Updated: 2019-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
115 participants
INTERVENTIONAL
2015-05-27
2016-05-20
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ASP3662
ASP3662 once daily (QD) and pregabalin placebo 3 times daily (TID) for Weeks 1 - 6. ASP3662 placebo QD and pregabalin placebo TID for Week 7.
ASP3662
oral
ASP3662 placebo
oral
pregabalin placebo
oral
pregabalin
pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.
pregabalin
oral
ASP3662 placebo
oral
Placebo
ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.
ASP3662 placebo
oral
pregabalin placebo
oral
Interventions
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ASP3662
oral
pregabalin
oral
ASP3662 placebo
oral
pregabalin placebo
oral
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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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
Site US10018
Clearwater, Florida, United States
Site US10019
DeLand, Florida, United States
Site US10004
Homestead, Florida, United States
Site US10042
Jacksonville, Florida, United States
Site US10007
Jupiter, Florida, United States
Site US10041
Miami Lakes, Florida, United States
Site US10046
Orlando, Florida, United States
Site US10008
Ormond Beach, Florida, United States
Site US10003
Oviedo, Florida, United States
Site US10049
The Villages, Florida, United States
Site US10009
Aurora, Illinois, United States
Site US10036
Chicago, Illinois, United States
Site US10025
Evansville, Indiana, United States
Site US10064
Metairie, Louisiana, United States
Site US10051
Boston, Massachusetts, United States
Site US10026
New Bedford, Massachusetts, United States
Site US10063
Quincy, Massachusetts, United States
Site US10043
Hazelwood, Missouri, United States
Site US10013
Kettering, Ohio, United States
Site US10014
Duncansville, Pennsylvania, United States
Site US10015
Greer, South Carolina, United States
Site US10034
Austin, Texas, United States
Site US10040
Houston, Texas, United States
Site US10032
San Antonio, Texas, United States
Site US10031
San Antonio, Texas, United States
Site US10033
Salt Lake City, Utah, United States
Site US10045
Renton, Washington, United States
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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3662-CL-0049
Identifier Type: -
Identifier Source: org_study_id
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