A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Phase 2

Completed

• Conditions: Diabetic Neuropathic Pain
• Interventions: Drug: placebo; Drug: ABT-894

• Registration Number: NCT00548925
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Study Start: 2007-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2011-09-21
• Disposition First Submitted QC: 2011-09-21
• Disposition First Posted: 2011-10-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	ABT-894	-

Primary Outcome Measures

Name	Time	Method
Weekly mean of 24-hour average pain score	Change from Baseline to final

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (29)

Site Reference ID/Investigator# 6614; 🇺🇸 Spring Valley, California, United States

Site Reference ID/Investigator# 6617; 🇺🇸 Walnut Creek, California, United States

Site Reference ID/Investigator# 6356; 🇺🇸 Hollywood, Florida, United States

Site Reference ID/Investigator# 6615; 🇺🇸 Tampa, Florida, United States

Site Reference ID/Investigator# 6358; 🇺🇸 Wellington, Florida, United States

Site Reference ID/Investigator# 6609; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 7229; 🇺🇸 New Hyde Park, New York, United States

Site Reference ID/Investigator# 6618; 🇺🇸 Charlotte, North Carolina, United States

Site Reference ID/Investigator# 6607; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 6575; 🇺🇸 Allentown, Pennsylvania, United States

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