A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Conditions
Pain
Intervention
Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR), Immediate Release Hydrocodone/Acetaminophen (NORCO® )
Status
Completed
Source
Abbott
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00404222
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hydrocodone
Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.
Msh Release-inhibiting Hormone
A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.
Thromboxane B2
A stable, physiologically active compound formed in vivo from the prostaglandin endoperoxides. It is important in the platelet-release reaction (release of ADP and serotonin).
Biohazard Release
Uncontrolled release of biological material from its containment. This either threatens to, or does, cause exposure to a biological hazard. Such an incident may occur accidentally or deliberately.
Somatostatin
A 14-amino acid peptide named for its ability to inhibit pituitary GROWTH HORMONE release, also called somatotropin release-inhibiting factor. It is expressed in the central and peripheral nervous systems, the gut, and other organs. SRIF can also inhibit the release of THYROID-STIMULATING HORMONE; PROLACTIN; INSULIN; and GLUCAGON besides acting as a neurotransmitter and neuromodulator. In a number of species including humans, there is an additional form of somatostatin, SRIF-28 with a 14-amino acid extension at the N-terminal.
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PubMed Articles
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The number of prescriptions for hydrocodone-containing opioid analgesics has greatly increased over the past decade. This increase has led to an associated enhancement in the non-medical use of hydroc...
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