An exploratory, randomised, double-blind, single-dummy, placebo controlled, parallel group study to demonstrate the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) in addition to pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from severe pain due to diabetic polyneuropathy

Mundipharma Research GmbH & Co. KG0 个研究点目标入组 80 人开始时间: 2009年2月13日最近更新: 2012年9月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Mundipharma Research GmbH & Co. KG
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

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 or female subjects at least 18 years (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
•2. Subjects with type 1 (IDDM) or type 2 (NIDDM) diabetes.
•3. Subjects with severe pain due to diabetic/idiopathic polyneuropathy for at least 3 months, confirmed by a score of = 7 for their average pain over last 24 hrs (Average Pain Scale, NRS 0 - 10, see section 12.5) and by a MNSI assessment score of = 2.5 at the Screening Visit that requires additional opioid therapy (20 - 80 mg OXN PR per day) for a minimum of 12 weeks.
•4. Subjects established on a maximum tolerated dose of pregabalin for at least 1 month but who are still experiencing severe pain.
•5. Subjects, who are receiving pregabalin up to a maximum daily dose of 600 mg as a compulsory treatment for the treatment of their neuropathic pain due to diabetic/idiopathic polyneuropathy.
•6. Subject’s whose pregabalin dose is < 150 mg per day the dose has to be justified based on the renal function (SPC pregabalin (Lyrica®)).
•7. Subjects with a documented history of optimisation of pain control with pregabalin.
•8. Subjects, whose pregabalin dose is expected to be stable throughout the
•double-blind phase.
•9. Subjects must not have reported constipation within the last 3 months, and subjects must not have taken laxative medication in the last 3 months before the start of the study.
•10. Subjects must not have received opioid containing medication in the last 6 months on a regular basis (i.e. prescribed medication or more than occasional self medication use for cough/cold etc).
•11. Subject’s non opioid analgesic medication dose is expected to be stable throughout the double-blind phase.
•12. In the Investigator’s opinion the subject’s non-analgesic concomitant medications, including those medications for the treatment of depression are thought to be stable, and will remain stable throughout the double-blind phase of the study.
•13. The subject’s diet is not expected to have significant alteration that may affect bowel function during the course of the study.
•Criteria for entry to the Double-blind phase:
•1. Subjects continue to satisfy screening inclusion/exclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range
•1. Male or female subjects at least 18 years (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
•2. Subjects with type 1 (IDDM) or type 2 (NIDDM) diabetes.
•3. Subjects with severe pain due to diabetic/idiopathic polyneuropathy for at least 3 months, confirmed by a score of = 7 for their average pain over last 24 hrs (Average Pain Scale, NRS 0 - 10, see section 12.5) and by a MNSI assessment score of = 2.5 at the Screening Visit that requires additional opioid therapy (20 - 80 mg OXN PR per day) for a minimum of 12 weeks.
•4. Subjects established on a maximum tolerated dose of pregabalin for at least 1 month but who are still experiencing severe pain.
•5. Subjects, who are receiving pregabalin up to a maximum daily dose of 600 mg as a compulsory treatment for the treatment of their neuropathic pain due to diabetic/idiopathic polyneuropathy.
•6. Subject’s whose pregabalin dose is < 150 mg per day the dose has to be justified based on the renal function (SPC pregabalin (Lyrica®)).
•7. Subjects with a documented history of optimisation of pain control with pregabalin.
•8. Subjects, whose pregabalin dose is expected to be stable throughout the
•double-blind phase.
•9. Subjects must not have reported constipation within the last 3 months, and subjects must not have taken laxative medication in the last 3 months before the start of the study.
•10. Subjects must not have received opioid containing medication in the last 6 months on a regular basis (i.e. prescribed medication or more than occasional self medication use for cough/cold etc).
•11. Subject’s non opioid analgesic medication dose is expected to be stable throughout the double-blind phase.
•12. In the Investigator’s opinion the subject’s non-analgesic concomitant medications, including those medications for the treatment of depression are thought to be stable, and will remain stable throughout the double-blind phase of the study.
•13. The subject’s diet is not expected to have significant alteration that may affect bowel function during the course of the study.
•Criteria for entry to the Double-blind phase:
•1. Subjects continue to satisfy screening inclusion/exclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Any history of hypersensitivity to oxycodone, naloxone, paracetamol, bisacodyl, pregabalin and related products or other ingredients of the provided medication.
•2. Any contraindication to oxycodone, naloxone, paracetamol, bisacodyl and other ingredients of the provided medication.
•3. Active alcohol or drug abuse and/or history of opioid abuse.
•4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
•5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range), gamma glutamyl transpeptidase (GGT or GGTP) = 5 times the upper limit of normal.
•6. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator’s opinion, may pose a risk of additional CNS depression with opioids study medication.
•7. Subjects with uncontrolled seizures or convulsive disorder.
•8. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period).
•9. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week double-blind phase that may affect GI motility or pain.
•10. Subjects presently taking, or who have taken, naloxone less than or equal 30 days prior to the start of the Screening Period.
•11. Subjects suffering from diarrhoea.
•12. Subjects with any situation in which opioids are contraindicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
•13. Subjects with myxoedema, hypothyroidism, Addison`s disease, increase of intracranial pressure.
•14. Previous treatment with oxycodone in combination with pregabalin.
•15. Patients with any co-existing condition that may produce pain independently of the neuropathic pain under study, and in the Investigator’s opinion may confound assessment of the patient’s neuropathic pain.
•1. Any history of hypersensitivity to oxycodone, naloxone, paracetamol, bisacodyl, pregabalin and related products or other ingredients of the provided medication.
•2. Any contraindication to oxycodone, naloxone, paracetamol, bisacodyl and other ingredients of the provided medication.
•3. Active alcohol or drug abuse and/or history of opioid abuse.
•4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
•5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range), gamma glutamyl transpeptidase (GGT or GGTP) = 5 times the upper limit of normal.
•6. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator’s opinion, may pose a risk of additional CNS depression with opioids study medication.
•7. Subjects with uncontrolled seizures or convulsive disorder.
•8. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period).
•9. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week double-blind phase that may affect GI motility or pain.
•10. Subjects presently taking, or who have taken, naloxone less than or equal 30 days prior to the start of the Screening Period.
•11. Subjects suffering from diarrhoea.
•12. Subjects with any situation in which opioids are contraindicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
•13. Subjects with myxoedema, hypothyroidism, Addison`s disease, increase of intracranial pressure.
•14. Previous treatment with oxycodone in combination with pregabalin.
•15. Patients with any co-existing condition that may produce pain independently of the neuropathic pain under study, and in the Investigator’s opinion may confound assessment of the patient’s neuropathic pain.

研究者

发起方

Mundipharma Research GmbH & Co. KG

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