An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Status and phase
Conditions
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Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
Full description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
- Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
- Outpatients
- Ambulatory participants without need for any supportive device or assistance during daily life
Exclusion criteria
- Participants with conditions for which opioids are contraindicated
- Participants with conditions for which acetaminophen is contraindicated
- Participants with history of convulsion or the possibility of convulsive seizure
- Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
- Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
Trial design
Primary purpose
Allocation
Interventional model
Masking
321 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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