CompletedPhase 2

Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis

670 participantsStarted 2004-07

Plain-language summary

The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum concentrations and safety of tapentadol and oxycodone were also examined.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months * Moderate to severe chronic pain due to knee osteoarithritis Exclusion Criteria: * Previously opioid treated subject who had a history of withdrawal after cessation of the opioid * History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate * Subjects with history of uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg) * Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.

Trial details

NCT IDNCT00745069

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Osteoarthitis trials