A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548925

Enrollment

124

Registered

2007-10-24

Start date

2007-11-30

Completion date

2008-12-31

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathic Pain

Brief summary

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

Interventions

DRUGABT-894

6 mg BID tablets, 8 weeks of treatment

DRUGplacebo

BID tablets, 8 weeks of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Males and females, age 18 to 75 * If female, must be of non-childbearing potential or practicing birth control * Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy * Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months * Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion criteria

* Has other conditions that may cause pain * Currently receiving analgesic medications for conditions other than diabetic neuropathic pain * Has a history of certain psychiatric diseases * Has a history of certain heart or cardiovascular conditions * Has any clinically significant recent infection, injury, or illness * Current participation in another clinical study or participation within the past 30 days * Is incapacitated, bedridden or confined to a wheelchair * Is pregnant and/or breastfeeding * Previous participation in this study or any other study with this investigational product.

Design outcomes

Primary

Measure	Time frame
Weekly mean of 24-hour average pain score	Change from Baseline to final

Secondary

Measure	Time frame
Pain improvement from Baseline to the final evaluation	8-week
Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain	8-week
Global assessments of study drug and pain status	8-week
Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)	8-week

Countries

Czechia, France, Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026