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

Painful Diabetic Peripheral Neuropathy (PDPN) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02372578
• Other study ID #: 3662-CL-0049
• Status: Terminated
• Phase: Phase 2
• Start date: May 27, 2015
• Est. completion date: May 20, 2016

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: May 20, 2016
• Est. primary completion date: May 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Peripheral Neuropathy (PDPN)
• Peripheral Nervous System Diseases

Intervention

Drug:
• ASP3662
oral
• pregabalin
oral
• ASP3662 placebo
oral
• pregabalin placebo
oral

Locations

Country	Name	City	State
United States	Site US10001	Anniston	Alabama
United States	Site US10009	Aurora	Illinois
United States	Site US10034	Austin	Texas
United States	Site US10051	Boston	Massachusetts
United States	Site US10005	Boynton Beach	Florida
United States	Site US10023	Bradenton	Florida
United States	Site US10036	Chicago	Illinois
United States	Site US10018	Clearwater	Florida
United States	Site US10019	DeLand	Florida
United States	Site US10014	Duncansville	Pennsylvania
United States	Site US10025	Evansville	Indiana
United States	Site US10053	Fairfield	Connecticut
United States	Site US10054	Fresno	California
United States	Site US10015	Greer	South Carolina
United States	Site US10043	Hazelwood	Missouri
United States	Site US10004	Homestead	Florida
United States	Site US10040	Houston	Texas
United States	Site US10042	Jacksonville	Florida
United States	Site US10007	Jupiter	Florida
United States	Site US10013	Kettering	Ohio
United States	Site US10020	Lomita	California
United States	Site US10064	Metairie	Louisiana
United States	Site US10041	Miami Lakes	Florida
United States	Site US10026	New Bedford	Massachusetts
United States	Site US10046	Orlando	Florida
United States	Site US10008	Ormond Beach	Florida
United States	Site US10003	Oviedo	Florida
United States	Site US10039	Phoenix	Arizona
United States	Site US10063	Quincy	Massachusetts
United States	Site US10045	Renton	Washington
United States	Site US10033	Salt Lake City	Utah
United States	Site US10031	San Antonio	Texas
United States	Site US10032	San Antonio	Texas
United States	Site US10047	Santa Monica	California
United States	Site US10049	The Villages	Florida
United States	Site US10017	Tustin	California
United States	Site US10055	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS	Numerical Pain Rating Scale (NPRS)	Baseline to Week 6/ End of Treatment (EOT)
Secondary	Percentage of Responders in mean 24-hour average pain intensity score		Baseline to Week 6/ EOT
Secondary	Change from Baseline in mean of 24-hour average pain intensity score		Baseline to Weeks 1, 2, 3, 4, 5 and 6
Secondary	Change from Baseline in mean daily worst pain score		Baseline to Week 6/ EOT
Secondary	Change from Baseline in mean daily average pain score		Baseline to Week 6/ EOT
Secondary	Patient Global Impression Change (PGIC)		Week 6/ EOT
Secondary	Clinical Global Impression of Change (CGIC)		Week 6/ EOT

External Links

•   Link to results on the Astellas Clinical Study Results website