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Abbott Vicodin CR study ‘shows positive results’
New clinical trials using Abbott’s investigational hydrocodone bitartrate and acetaminophen (HC/APAP) extended release medicine Vicodin CR showed that the treatment “significantly lowered” chronic low back pain compared to placebo, the company has announced.
In addition, the trial also tested a 12-hour dose of the treatment, an improvement on many of the HC/APAP combinations currently available, which are short-acting and have to be taken every four to six hours.
The study initially involved a sample of 773 patients. Each participant received two HC/APAP extended release tablets twice daily for a three-week “open-label period” after which 511 went on to the double blind trial, where they were randomly selected to receive one tablet of HC/APAP extended release, two tablets of HC/APAP extended release or a placebo twice a day.
Abbott’s vice-president of global pharmaceutical development Eugene Sun MD said: “These new extended-release data are encouraging because they showed that 12-hour dosing provided pain relief in patients with moderate to severe chronic low back pain.”
According to medinfo.co.uk, the main causes of low back pain are strains to the muscles, ligaments or tendons connected to the back’s vertebrae. The pain is considered chronic if it persists for more than 12 weeks.
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