Summary:
A phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal study to evaluate the analgesic efficacy, safety, and tolerability of study medication in subjects with moderate to severe chronic low back pain.
Qualified Participants Must:
• Have a clinical diagnosis of moderate to severe low back pain for greater than six months
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Be treating their low back pain with daily analgesic medication for more than four weeks
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Not have cancer related pain or have been treated with chemotherapy in the last five years
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Not have a history of other chronic painful conditions which require frequent anagesic medication such as chronic headaches, fibromyalgia, gout, diabetic neuropathy, etc.
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Not have clinically significant sleep apnea
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Not have received a steroid injection within last three months
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Not have had a surgical procedure for pain relief within last six months
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Not have received nerve block within last month
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Not have unstable cardiac disease or personal or family history of long QT syndrome
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Not have used class 1A or class III anti-arrhythmic medications within last two weeks
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Not have a history of moderate to severe hepatic impairment, renal impairment or creatinine clearance
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Not be HIV, Hep B or Hep C positive
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Not have concurrent or past history (within five years) of alcohol or substance abuse or dependence
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Not be using hypnotics or central nervous system depressants within last 14 days
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Not have a history of seizures, convulsions or significant head injury within last six months
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Not have a history of significant chronic obstructive pulmonary disease or bronchial asthma
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Not be involved in any ongoing litigation including workmen's compensation or other disability claims
Qualified Participants May Receive:
Study drug and procedures at no cost and compensation for time and travel up to $1,000.