EUCTR2011-005061-20-DK进行中（未招募）不适用
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, 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 Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clockOpioid Therapy - CONVERGE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
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 aged 18 years or older with a clinical diagnosis of low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening visit (visit 1).
- •2. The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation (Quebec Task Force Classification 1 to 3)
- •3. Subjects must require opiod 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 opiod therapy for the duration of the study.
- •4. Subjects must be:
- •a. On ongoing around-the-clock 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),
- •b. 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.
- •5. For subjects on <40 mg of morphine or equivalent per day, both the
- •average pain over the last 24 hours and the average pain over the
- •past 14 days scores at the screening (visit 1) must be = 5.
- •6. Subjects must have a self-reported history of OIC as defined by having
- •had while on opioids <3 complete spontaneous bowel movements
- •(CSBM) per week and 1 or more of the following for at least
- •25% of bowel movements (BMs):
- •a. Hard or lumpy stools
- •b. Straining during bowel movements
- •c. A sensation of incomplete evacuation after bowel movements
- •A CSBM is defined as a spontaneous bowel movement (SBM) that is
- •accompanied by the subject self reporting a feeling of complete
- •evacuation. An SBM is defined as a bowel movement occurring in the
- •absence of laxative or enema use in the previous 24 h.
- •7. Subjects must be willing to discontinue their current laxative regimen, including prokinetic drugs (e.g., metoclopramide).
- •8. Subjects must agree to the use of oral bisacodyl as their only laxative
- •rescue medication. Subjects taking daily fiber supplements, bulking
- •agents, probiotics, or macrobiotics are eligible if they are
- •maintained on a stable regimen for the 2 weeks before visit 1 and are
- •willing to maintain that regimen throughout the study, and, in the
- •investigator's opinion, they are willing and able to maintain adequate
- •9. For subjects receiving adjunct therapy (such as transcutaneous
- •electrical nerve stimulation (TENS), physical therapy, biofeedback
- •therapy, relaxation therapy, acupuncture therapy, herbal remedies, or
- •nutraceuticals), 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 (4 weeks for
- •glucosamine and/or chondroitin sulfate) before the screening visit (visit
- •1) and remain unchanged during the study.
- •10. 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.
- •11. Female subjects who are premenopausal or postmenopausal less
- •than 1 year, or who have not had surgical sterilization (i.e., tubal
- •ligation, partial or complete hysterectomy) must have a negative serum
- •pregnancy test, be nonlactating, and willing to use adequate and reliable contraception throughout the study (e.g., barrier
排除标准
- •1. Subjects with any contraindication or any history of hypersensitivity
- •to oxycodone, naloxone, or other opioids. This does not include subjects
- •who have experienced common opioid side effects (e.g., nausea,
- •constipation).
- •2. Subjects with any contraindication to bisacodyl.
- •3. Subjects with neurologic signs, or presumptive or confirmed
- •compression of a spinal nerve root (i.e., Quebec Task Force Classification 4 to 6)
- •4. Subjects with acute spinal cord compression, acute compression
- •fracture, seronegative spondyloarthropathy, acute nerve root
- •compression, cauda equina compression, fibromyalgia, reflex
- •sympathetic dystrophy or causalgia (complex regional pain syndrome),
- •diabetic amyotrophy, meningitis, discitis, or back pain due to secondary
- •infection, tumor, or postherpetic neuralgia.
- •5. Subjects with gout, unless controlled on stable suppressive treatment
- •with colchicine or uric-acidlowering therapy without any attacks for = 2
- •years and the subject has not been using NSAIDs or COX-2 inhibitors on
- •a regular basis.
- •6. Subjects with pseudogout, psoriatic arthritis, active Lyme disease,
- •rheumatoid arthritis or other inflammatory arthritis. Subjects with
- •neuropathic conditions that have been painful or required therapy
- •(such as gabapentin or other neuropathic pain treatments) within the
- •past 3 months are also excluded.
- •7. Subjects who, in the opinion of the investigator, are exhibiting
- •significant opioid withdrawal such that they should not be in the study.
- •8. Subjects with evidence of significant structural abnormalities of the
- •gastrointestinal tract (e.g., bowel obstruction, strictures) or any
- •diseases/conditions that affect bowel transit (e.g., ileus, uncontrolled
- •hypothyroidism).
- •9. Subjects with a history of prior chronic constipation (including
- •functional constipation or pelvic floor dyssynergy) that was present for
- •more than three months and that was not related to opioid use.
- •10. Subjects currently with clinically diagnosed diarrhea, defined as 3
- •stools/day that are loose or watery in nature within 2 weeks before visit
- •11. Subjects with irritable bowel syndrome (IBS) or inflammatory bowel
- •disease (e.g., ulcerative colitis, Crohn's disease).
- •12. 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.
- •13. Subjects with a history of fecal incontinence.
- •14. Subjects who require ongoing therapy with medications (other than
- •opioids) that have contributed to the subjects' constipation in the
- •judgment of the investigator.
- •15. Subjects with hereditary problems of galactose intolerance, Lapp
- •lactase deficiency, or glucosegalactose malabsorption.
- •16. Subjects who cannot or will not agree to completely stop all
- •incoming opioid and nonopioid analgesic medications and other
- •medications used for chronic pain (excluding herbal and neutraceutical
- •medications as per the inclusion criteria 10). NSAIDs, aspirin, COX-2
- •inhibitors, and acetaminophen may be used intermittently during the
- •course of the study for headache, fever, or acute pain other than
- •low back pain; low dose aspirin for cardiovascular disease prophylaxis is
- •allowed. Muscle relaxants may be used intermittently during the course
- 另有 4 项未显示
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, controlled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.Opioid-induced Constipation & Moderate to Severe Chronic Low back PainMedDRA version: 14.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.1Level: PTClassification code 10003988Term: Back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-005061-20-CZPurdue Pharma L.P.900
进行中（未招募）
不适用
A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, uncontrolled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.Opioid-induced Constipation & Moderate to Severe Chronic Low back PainMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-005060-26-ITPURDUE PHARMA L.P.900
进行中（未招募）
不适用
A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, uncontrolled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.Opioid-induced Constipation & Moderate to Severe Chronic Low back PainMedDRA version: 17.0Level: PTClassification code 10003988Term: Back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 17.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856EUCTR2011-005060-26-CZPurdue Pharma L.P.600
进行中（未招募）
不适用
A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, uncontrolled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.Opioid-induced Constipation & Moderate to Severe Chronic Low back PainMedDRA version: 14.1Level: PTClassification code 10003988Term: Back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 14.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856EUCTR2011-005061-20-SKPurdue Pharma L.P.900
进行中（未招募）
不适用
A clinical trial to assess the effectiveness of oxycodone/naloxone combination drug on severe, ongoing, controlled low back pain and opioid induced constipation, in patients already taking opioids for the management of this pain.EUCTR2011-005061-20-PLPurdue Pharma L.P.900