Clinical trial NCT00736853: An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Official title: A Phase 3 Study of JNS013 in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Chronic pain
Acetoaminophen
Tramadol
Osteoarthritis of the knee
Low back pain
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 321
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
timeFrame: Day 28 of double-blind period
Secondary outcomes:
measure: Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period
timeFrame: Day 1 of open-label period and Day 1 of double-blind period
measure: Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period
timeFrame: Day 1 and Day 28 of double-blind period
measure: Mean Pain Intensity (PI) Score During Open-Label Period
timeFrame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
measure: Mean PI Score During Double-Blind Period
timeFrame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
measure: Mean Pain Intensity Difference (PID) During the Open-Label Period
timeFrame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period
measure: Mean PID During the Double-Blind Period
timeFrame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period
measure: Mean Pain Relief (PAR) Score During the Open-Label Period
timeFrame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
measure: Mean PAR Score During the Double-Blind Period
timeFrame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
measure: Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period
timeFrame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period
measure: Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period
timeFrame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period
measure: Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period
timeFrame: Day 1, and Day 8 of open-label period
measure: Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period
timeFrame: Day 1, 8, 15, 22 and 28 of double-blind period
measure: Total Pain Relief (TOTPAR) Score During the Open-Label Period
timeFrame: Day 1 and Day 8 of open-label period
measure: Total Pain Relief (TOTPAR) Score During the Double-Blind Period
timeFrame: Day 1, 8, 15, 22 and 28 of double-blind period
measure: Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period
timeFrame: Day 1, and Day 8 of open-label period
measure: Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period
timeFrame: Day 1, 8, 15, 22 and 28 of double-blind period
measure: Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period
timeFrame: Day 1 and Day 14 of open-label period
measure: Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period
timeFrame: Day 1 and Day 28 of double-blind period
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period
timeFrame: Day 1 and Day 14 of open-label period
measure: Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period
timeFrame: Day 1 and Day 28 of double-blind period
measure: Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period
timeFrame: Day 1 and Day 14 of open-label period
measure: Change From Baseline in SF-36 at Day 28 of Double-Blind Period
timeFrame: Day 1 and Day 28 of double-blind period
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Amagasaki
country: Japan
city: Chiba N/A
country: Japan
city: Chiba
country: Japan
city: Edogawa
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Iruma
country: Japan
city: Kagoshima
country: Japan
city: Kawasaki
country: Japan
city: Kumagaya
country: Japan
city: Kurume
country: Japan
city: Meguro
country: Japan
city: Minato
country: Japan
city: Niigata N/A
country: Japan
city: Niigata
country: Japan
city: Ohta-Ku
country: Japan
city: Okazaki
country: Japan
city: Sagamihara
country: Japan
city: Setagaya
country: Japan
city: Shibuya
country: Japan
city: Shinjuku-Ku
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: