A Randomized, Double-blind, Double-dummy, Placebo-controlled, Activecontrolled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlledrelease Tablets (OXY)) 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 - CONVERGE

PURDUE PHARMA L.P.0 个研究点目标入组 900 人开始时间: 2012年8月7日最近更新: 2015年3月30日

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阶段: 不适用
状态: 进行中（未招募）
发起方: PURDUE PHARMA L.P.
入组人数: 900

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研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male and female subjects = 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period. 2. The low back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee); i.e., meeting Quebec Task Force Classification 1 or 2 19-21 3. Subjects must be - On ongoing opioid analgesic medication for at least 4 weeks prior to the screening visit (visit 1) and on a stable dose of opioid analgesic medication equivalent to 20 to 160 mg (inclusive) of morphine per day for the last 2 weeks prior to the screening visit (visit 1) or Taking 0 to less than 20 mg of morphine or its equivalent per day for the last 2 weeks prior to the screening visit (visit 1) due to OIC 4. Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study. 5. Subjects must have an average pain over the last 14 days score = 5 at the screening visit 6. Subjects must have an average pain over the last 24 hours score = 5 at the screening visit 7. Subjects must have a reported history of OIC, defined as having had while on opiods <3 spontaneous bowel movements per week and 1 or more of the following for at 25% of SBMs: - hard or lump stools - straining during bowel movements - A sensation of incomplete evacuation after bowel movements Where an SBM is defined as a bowel moevment occurring in the absence of laxative or enema use in the previous 24 h. 8. Subjects must be willing to discontinue their current laxative regimen 9. Subjects must agree to the use of oral bisacodyl as their only laxative rescue medication. 10. For subjects receiving adjunct therapy such treatment must be stopped before treatment with OXY is initiated, or, if continued, the treatment should have been at a stable dose/intensity and frequency for 2 weeks before the screening visit (visit 1) and remain unchanged during the study. 11. If taking oral corticosteroids, subjects must be on at a stable dose for at least 6 weeks before the screening visit (visit 1) and be willing to maintain that dose throughout the study. 12. Female subjects who are premenopausal or postmenopausal less than 1 year, or who have not had surgical sterilization must have a negative serum pregnancy test 13. Subjects who are willing and able to be compliant with the protocol, and who provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 899
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

排除标准

•Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids,Subjects with any contraindication to bisacodyl,Subjects with pain with distal radiation with or without neurologic signs, or presumptive or confirmed compression of a spinal nerve rootSubjects with acute spinal cord compression, acute compression fracture, seronegativespondyloarthropathy, acute nerve rootcompression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgiaSubjects with gout, unless controlled on stable suppressive treatmentwith colchicine or uricacid-lowering therapy without any attacks for = 2years and the subject has not been using NSAIDs or COX-2 inhibitors on a regular basis.Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic painconditionsSubjects who, in the opinion of the investigator, are exhibiting significant opioid withdrawal such that they should not be in the study.Subjects with evidence of significant structural abnormalities of thegastrointestinal tract or any diseases that affect bowel transit Subjects with a history of prior chronic constipationthat was present for more than three months and that was not related to opioid use.Subjects currently with clinically diagnosed diarrhea, defined as 3 stools/day within 2 weeks before visit 2.subjects with irritable bowel syndrome (IBS) or inflammatory bowel disease.Subjects who had surgery that may affect gastrointestinal motility or gastrointestinal pain within 2 months prior to the start of the screening period, or who plan such surgery during the study.Subjects with a history of fecal incontinence.Subjects who require ongoing therapy with medications (other than opioids) that have contributed to the subjects' constipationSubjects with hereditary problems of galactose intolerance,or glucose-galactose malabsorption.Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic painSubjects who cannot or will not agree to forego the following treatments during the study: nerve/plexus blocks or ablation, neurosurgical procedures for pain control, Botulinum toxin injections for pain control in the lumbar spine, steroid injections in the lumbar spine, or inhalation analgesia. 18. Subjects who had surgical procedures directed towards the source ofchronic low back pain within 6 months of the screening orplannedSubjects with a history of malignancy within past 2 years, withexception of basal cell carcinoma that has been successfully treated.Subjects with current uncontrolled depression or other uncontrolledpsychiatric disorderSubjects with an average QTcF of > 470 msec at the screening visit will be excluded.Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit (visit 1). 23. Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time. 24. Subjects with evidence of impaired liver function and impaired kidney function upon entry into the studySubjects with increase of intracranial pressure and/or epilepsy 26. Subjects with clinically significant cardiova

研究者

发起方

PURDUE PHARMA L.P.

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