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A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety

NCT ID: NCT02065349

Last Updated: 2017-11-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-24

Study Completion Date

2015-02-13

Brief Summary

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The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.

Detailed Description

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The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.

Conditions

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Post-Herpetic Neuralgia (PHN) Neuropathic Pain Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

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peripheral neuropathy PHN pain PDPN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

ASP8477

oral

Group Type ACTIVE_COMPARATOR

ASP8477

Intervention Type DRUG

oral

Interventions

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ASP8477

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PDPN subject must have:

* Established diagnosis of diabetes (type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HbA1c) ≤ 11% at Screening.
* Stable glycemic control (HbA1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to Screening.
* At least a 1-year history of DPN pain.
* Diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to Screening based on PI judgment and subject-reported medical history.
* PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.

Exclusion Criteria

* Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
* Previous investigational therapy within 28 days or 5 half lives
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Site: CZ42003

Choceň, , Czechia

Site Status

Site: CZ42004

Litomyšl, , Czechia

Site Status

Site: CZ42011

Olomouc, , Czechia

Site Status

Site: CZ42014

Prague, , Czechia

Site Status

Site: CZ42001

Rychnov nad Kněžnou, , Czechia

Site Status

Site: CZ42002

Slezská Ostrava, , Czechia

Site Status

Site: DE49003

Cologne, , Germany

Site Status

Site: DE49005

Neuss, , Germany

Site Status

Site: PL48003

Bialystok, , Poland

Site Status

Site: PL48004

Poznan, , Poland

Site Status

Site: PL48001

Poznan, , Poland

Site Status

Site: PL48002

Torun, , Poland

Site Status

Site: PL48005

Warsaw, , Poland

Site Status

Site: GB44001

Glasgow, Scotland, United Kingdom

Site Status

Site: GB44003

Ipswich, , United Kingdom

Site Status

Site: GB44006

London, , United Kingdom

Site Status

Site: GB44002

Manchester, , United Kingdom

Site Status

Countries

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Czechia Germany Poland United Kingdom

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=217

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

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2013-002521-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8477-CL-0020

Identifier Type: -

Identifier Source: org_study_id