Expired Study
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Clinical Trial 4572

Oklahoma City, OK 73119

Study Summary:

We are currently conducting a clinical research study sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. The study is evaluating the safety and effectiveness of Tapentadol, an investigational medicinal product for the treatment of acute pain caused by vertebral compression fractures associated with osteoporosis.

The primary objective of this study is to determine the efficacy and safety of investigational tapentadol immediate release (IR) as compared with oxycodone IR and placebo in subjects with acute pain.

Qualified participants who choose to join the study will be enrolled for a period of up to twelve (12) days and will visit the clinic on at least 2 occasions. Upon study entry, enrolled participants will be randomly assigned to receive either tapentadol, oxycodone, or placebo for up to 12 consecutive days.

Qualified Participants Must:

• Be 50-85 years of age, inclusive
• Be able to begin treatment within fourteen (14) days of new onset of pain or acute exacerbation of previous pain associated with a VCF.
• Have radiographic confirmation of a VCF (one or two VCFs in the thoracolumbar region) prior to study entry.
• Not have taken the following exclusionary medications:
• Long-acting or controlled release opioid within one month prior to Visit 1.
• Immediate release CII opioid formulations within one month prior to Visit1.
• Any CIII opioid formulation >5 days/week in the one month prior to Visit 1.
• Be able to give informed consent and to verbalize and differentiate with regard to location and intensity of his/her pain.

Qualified Participants May Receive:

You will get a total of up to $200 if you finish the whole study. If you do not finish the whole study, you will get $100 for each study visit you finish. The study doctor or study staff can tell you more about when you will get paid.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.