321
Participants
Start Date
June 30, 2008
Primary Completion Date
January 31, 2009
Study Completion Date
January 31, 2009
Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).
Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.
Placebo (Double-Blind)
Matching placebo will be given up to 4 weeks.
Aichi
Amagasaki
Chiba
Edogawa City
Fukuoka
Fukushima
Iruma
Kagoshima
Kawasaki
Kumagaya
Kurume
Meguro City
Minato
Niigata
Ohta-Ku
Okazaki
Sagamihara
Setagaya City
Shibuya City
Shinjuku-Ku
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY