11
Participants
Start Date
October 31, 2007
Primary Completion Date
December 31, 2011
Study Completion Date
June 30, 2014
hydrocodone/APAP w placebo PRN
Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid three times daily (TID). With liquid placebo available PRN.
hydrocodone/APAP
Participants judged as responders during Phase A continue the same dose of study medication (hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID). Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.
placebo with hydrocodone/APAP PRN
Liquid placebo PRN. Also available PRN is Hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid.
Tuscaloosa VA Medical Center, Tuscaloosa
Tuscaloosa Veterans Affairs Medical Center, Tuscaloosa
VA Medical Center, Tuscaloosa, Tuscaloosa
VA Office of Research and Development
FED