A Phase 2 interventional study of ABT-639 and pregabalin in Diabetic Neuropathic Pain, sponsored by AbbVie (prior sponsor, Abbott). Completed at 35 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-08.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 193 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ABT-639 twice daily for 6 weeks
Drug: ABT-639
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
Drug: pregabalin
Placebo twice daily for 6 weeks
Drug: Placebo
ABT-639 Twice Daily for six weeks.
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Also known as: Lyrica
Placebo twice daily for 6 weeks.
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Daily questions asked on a hand held diary
Time frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Patient's Global Impression of Change
Paper questionnaire
Time frame: Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Paper questionnaire
Time frame: At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Paper questionnaire
Time frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott)