Trial Information

A research study is currently underway in your area to test the safety and effectiveness of an investigational medication to help treat moderate-severe low back pain and the constipation that may occur in people taking prescription pain medications.

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of XXXXX Tablets (XXX) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to XXXXXXX release Tablets (XXX) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the clock Opioid Therapy

Patient Inclusion Criteria:

Over the Age of 18 with moderate to severe, chronic back pain
The LBP must be related to nonmalignant and nonneuropathic conditions
Subjects must be: Opioid analgesic medication for at least 4 weeks
Subjects must require continuation of opioid treatment in the range of 40-160mg
Subject must have an average pain over the last 14 days, 5 on an 11-point NRS
Subjects must have reported OIC defined as having while on opioids less than 3 bowel movements per week and 1 or more of the following (hard or lumpy stool)(Straining)(A sensation of incomplete after bowel movement)
Subjects must be willing to discontinue their current laxative regime
Subjects must agree to use oral bysacodyl as their only oral laxative
Subjects who are willing and able to be compliant with the protocol, and who provide written informed consent.

Patient Exclusion Criteria:

Subjects with any contraindication of hypersensitivity to oxycodone, nalaxone, ot other opioids.
Subject with any contraindication to Bisacodyl
Subjects with pain with distal radiation below the knee with or without neurologic signs
Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression fracture, cauda equina compression, fybromyalgia, reflex sympathetic dystrophy or causalgia, diabetic amyotrophy, meningitis, discitis, or due to secondary infection, tumor or neuralgia.
Subjects with Gout, Psedogout, Psoriatic arthritis, active Lyme disease, RA or neuropathic pain conditions.
Subjects with IBS
Subjects with clinical diagnosed diarrhea
Subjects with Crohn's disease
Subjects with history of fecal incontinence
Subjects with galactolose intolerance
Subjects who cannot or will no agree to stop completely al incoming opioid and nonopioid analgesic treatments
Subject who cannot or will not agree to forego the following treatment during the study(nerve/plexus blocks or ablation, neurosurgical procedures for pain, botullinum toxin injections for pain control in the lumbar spine, steroid injections or inhalation analgesia.
Subjects who had surgical procedures directed towards the source of chronic low back pain
Subjects with uncontrolled depression or psychiatric problem
Subjects with evidence of impaired liver.
Subjects with evidence of impaired kidney upon entry the study.
Subjects with history of alcohol abuse.
Subjects with a positive result on urine drug testing for illicit drugs.
Subjects who had received a monoamine oxidase inhibitor within the last 14 days prior to screening visit.
Subjects with Epilepsy.
Subjects with significant cardiovascular disease or dysrhythmias.
Subjects with biliary tract disease, hypothyrodism, adrenal cortical insufficient.
Subjects with an ongoing Workman's compesation claim.
Subjects who have received a study drug in a clinical studu of OXN or ONU.

Luis Estevez, Clinical Research Coordinator
IMA Research
1431 NW 13th
Miami, FL 33125
Phone: 866-879-2507 ext 705
Fax: 866-777-8019
Email: luis.estevez@imaresearch.com

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Research Center Information: IMA Research

If you would like to learn more about participating in this study, please send an email message using the form below.

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