Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT02372578|
Recruitment Status : Terminated (The study was terminated due to futility analysis.)
First Posted : February 26, 2015
Last Update Posted : March 26, 2019
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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).
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Peripheral Neuropathy (PDPN)||Drug: ASP3662 Drug: pregabalin Drug: ASP3662 placebo Drug: pregabalin placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||May 27, 2015|
|Actual Primary Completion Date :||May 20, 2016|
|Actual Study Completion Date :||May 20, 2016|
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.
Drug: ASP3662 placebo
Drug: pregabalin placebo
Active Comparator: pregabalin
pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.
Drug: ASP3662 placebo
Placebo Comparator: Placebo
ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.
Drug: ASP3662 placebo
Drug: pregabalin placebo
- Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS [ Time Frame: Baseline to Week 6/ End of Treatment (EOT) ]Numerical Pain Rating Scale (NPRS)
- Percentage of Responders in mean 24-hour average pain intensity score [ Time Frame: Baseline to Week 6/ EOT ]
- Change from Baseline in mean of 24-hour average pain intensity score [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5 and 6 ]
- Change from Baseline in mean daily worst pain score [ Time Frame: Baseline to Week 6/ EOT ]
- Change from Baseline in mean daily average pain score [ Time Frame: Baseline to Week 6/ EOT ]
- Patient Global Impression Change (PGIC) [ Time Frame: Week 6/ EOT ]
- Clinical Global Impression of Change (CGIC) [ Time Frame: Week 6/ EOT ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject has a BMI ≤ 40.
Subject has all of the following:
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372578
|Study Director:||Senior Medical Director||Astellas Pharma Global Development, Inc.|
|Responsible Party:||Astellas Pharma Global Development, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 26, 2015 Key Record Dates|
|Last Update Posted:||March 26, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."|
Painful diabetic peripheral neuropathy (PDPN)
Peripheral Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Central Nervous System Depressants