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Last Updated: October 23, 2019

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CLINICAL TRIALS PROFILE FOR ROXICODONE

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Clinical Trials for Roxicodone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00853216 Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets Completed Mallinckrodt Phase 1 2003-01-01 The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.
NCT00853320 Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets Completed Mallinckrodt Phase 1 2003-02-01 The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 15 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.
NCT00853736 Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets Completed Mallinckrodt Phase 1 2003-02-01 The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fed conditions.
NCT00978328 Oxycodone User Registry (OUR) Completed Ortho-McNeil Janssen Scientific Affairs, LLC N/A 2009-06-01 The purpose of this study is to describe clinical and demographic characteristics of patients receiving prescription medications containing oxycodone immediate release (OXYRX), to characterize patient and prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment, to describe prescriber decision-making about pain management with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain medications.
NCT01500317 Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans Completed National Center for Research Resources (NCRR) Phase 4 2011-05-01 Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is potential for off label use in chronic pain. Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in pain relief. While its action reflects aspects of tramadol and morphine, its ability to control pain is more on the order of hydrocodone and oxycodone. Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain in various pain care settings. In addition, it was reported to be associated with significantly fewer treatment discontinuations due to a significantly lower incidence of gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The combination of these reduced treatment discontinuation rates and tapentadol efficacy for the relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in pain therapy by increasing patient compliance with their treatment regimen.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Roxicodone

Condition Name

Condition Name for Roxicodone
Intervention Trials
Healthy 4
Malignant Neoplasms of Female Genital Organs 1
Gynecologic Cancer 1
Unilateral Knee Arthroplasty 1
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Condition MeSH

Condition MeSH for Roxicodone
Intervention Trials
Neoplasms 1
Genital Neoplasms, Female 1
Muscle Hypotonia 1
Pain, Postoperative 1
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Clinical Trial Locations for Roxicodone

Trials by Country

Trials by Country for Roxicodone
Location Trials
United States 9
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Trials by US State

Trials by US State for Roxicodone
Location Trials
Missouri 3
Maryland 1
Texas 1
Florida 1
North Carolina 1
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Clinical Trial Progress for Roxicodone

Clinical Trial Phase

Clinical Trial Phase for Roxicodone
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Roxicodone
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Suspended 1
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Clinical Trial Sponsors for Roxicodone

Sponsor Name

Sponsor Name for Roxicodone
Sponsor Trials
Mallinckrodt 3
University of North Carolina, Chapel Hill 1
Johns Hopkins University 1
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Sponsor Type

Sponsor Type for Roxicodone
Sponsor Trials
Industry 7
Other 6
NIH 1
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