A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT01345045|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : January 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathic Pain||Drug: ABT-639 Drug: pregabalin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
ABT-639 twice daily for 6 weeks
ABT-639 Twice Daily for six weeks.
Active Comparator: pregabalin
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Other Name: Lyrica
Placebo Comparator: Placebo
Placebo twice daily for 6 weeks
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 [ Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) ]Daily questions asked on a hand held diary
- Patient's Global Impression of Change [ Time Frame: Week 2, Week 4 and Week 6 (End of Study) ]Paper questionnaire
- Brief Pain Inventory (BPI) (short form) including Severity and Interference [ Time Frame: At each visit up to Week 6 (end of Study) ]Paper questionnaire
- Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study) ]Paper questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345045
Show 35 Study Locations
|Study Director:||Rachel Duan, MD||AbbVie|