A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00548925
• Date of registration: 22/10/2007
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
• Scientific 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
• Date of first enrolment: November 2007
• Target sample size: 124
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00548925
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Czech Republic, France, Germany, Italy, Spain, United Kingdom, United States

Contacts

• Name: Rachel Duan, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetic Neuropathic Pain

Intervention(s)

Drug: ABT-894

Drug: placebo

Primary Outcome(s)

Weekly mean of 24-hour average pain score [Time Frame: Change from Baseline to final]

Secondary Outcome(s)

Global assessments of study drug and pain status [Time Frame: 8-week]

Pain improvement from Baseline to the final evaluation [Time Frame: 8-week]

Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain [Time Frame: 8-week]

Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) [Time Frame: 8-week]

Secondary ID(s)

M10-014

2007-001140-47

Source(s) of Monetary Support

Please refer to primary and secondary sponsors