An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

321

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Pain
Interventions
DRUG

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).

DRUG

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.

DRUG

Placebo (Double-Blind)

Matching placebo will be given up to 4 weeks.

Trial Locations (20)

Unknown

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

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT00736853 - An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain | Biotech Hunter | Biotech Hunter