A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2009

Conditions
Chronic Pain
Interventions
DRUG

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.

Trial Locations (25)

Unknown

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

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT00736957 - A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain | Biotech Hunter | Biotech Hunter