We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    ASP3662

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief 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).


Condition or disease Intervention/treatment Phase
Painful Diabetic Peripheral Neuropathy (PDPN) Drug: ASP3662 Drug: pregabalin Drug: ASP3662 placebo Drug: pregabalin placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: 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.
Drug: ASP3662
oral

Drug: ASP3662 placebo
oral

Drug: pregabalin placebo
oral

Active Comparator: pregabalin
pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.
Drug: pregabalin
oral

Drug: ASP3662 placebo
oral

Placebo Comparator: Placebo
ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.
Drug: ASP3662 placebo
oral

Drug: pregabalin placebo
oral




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Percentage of Responders in mean 24-hour average pain intensity score [ Time Frame: Baseline to Week 6/ EOT ]
  2. Change from Baseline in mean of 24-hour average pain intensity score [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5 and 6 ]
  3. Change from Baseline in mean daily worst pain score [ Time Frame: Baseline to Week 6/ EOT ]
  4. Change from Baseline in mean daily average pain score [ Time Frame: Baseline to Week 6/ EOT ]
  5. Patient Global Impression Change (PGIC) [ Time Frame: Week 6/ EOT ]
  6. Clinical Global Impression of Change (CGIC) [ Time Frame: Week 6/ EOT ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Information from the National Library of Medicine

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


Locations
Show Show 37 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Layout table for investigator information
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02372578    
Other Study ID Numbers: 3662-CL-0049
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."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Painful diabetic peripheral neuropathy (PDPN)
ASP3662
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs