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Completed

NCT Number: NCT00548925

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

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

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Key information

Conditions

Diabetic Neuropathic Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 5552, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-894

Drug

6 mg BID tablets, 8 weeks of treatment

Placebo

Drug

BID tablets, 8 weeks of treatment

Primary outcomes

  1. Weekly mean of 24-hour average pain score

    Time frame: Change from Baseline to final

Secondary outcomes

  1. Pain improvement from Baseline to the final evaluation

    Time frame: 8-week

  2. Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain

    Time frame: 8-week

  3. Global assessments of study drug and pain status

    Time frame: 8-week

  4. Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)

    Time frame: 8-week

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2007
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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