219
Participants
Start Date
May 31, 2008
Primary Completion Date
October 31, 2009
Study Completion Date
November 30, 2009
Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)
Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.
Chikushi
Chūō
Fukui
Fukuoka
Hiratsuka
Ichikawa
Kashiwa
Komatsu
Kukichūō
Kumamoto
Kyoto
Mihara
Nagoya
Nerima City
Obihiro
Ogi
Ohta-Ku
Osaka
Tagawa
Taito-Ku
Takaoka
Tokyo
Urayasu
Yame
Yokohama
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY