EUCTR2006-003233-32-SE进行中（未招募）不适用
A randomized, open, controlled parallel group, multi-center study to evaluate the efficacy and safety of Norspan versus Tiparol Retard in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Males and females more than 18 years of age (women of child bearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, hormonal, condom + spermicide) throughout the study).
- •2. Clinical diagnosis of OA of the hip and/or knee including fulfillment of ACR-criteria (American College of Rheumatology Criteria) and radiographic evidence (Appendix E).
- •3. Subjects with moderate to severe pain, confirmed by a BS-11 score > 4 for their pain on average during the last week, in their primary OA joint at the Baseline Visit (Randomization Visit).
- •4. Subjects should previous have been treated with 4000 mg Paracetamol IR daily and not been adequately pain relieved (BS-11 score > 4 for their pain on average during the last week, in their primary OA joint) on that treatment.
- •5. All pain treatment (incl. glucoseamine) must be discontinued from the Screening Visit until the Completion/Discontinuation Visit. Only sponsor provided Paracetamol tablets shall be used.
- •6. Subject must be able to read and comprehend national language (Swedish) and be willing to sign informed consent.
- •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. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan®)) for their OA pain.
- •2. Subjects treated with a regular dose for > 1 week of tramadol, codeine or dextropropoxifene during the last three months.
- •3. History of chronic condition(s), in addition to OA, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
- •4. Scheduled for surgery that would fall within the Screening Phase or Treatment Phase of the study.
- •5. Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
- •6. Patients with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
- •7. Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
- •8. Subjects, who are currently taking hypnotics or other central nervous system depressants that, in the Investigator’s opinion, may pose a risk of additional CNS depression with study medication.
- •9. Subjects who are currently taking adjuvant analgesics such as antidepressants (e.g. amitriptyline, amoxapine, clomipramine, selective serotonin re-uptake inhibitors (SSRI’s)) and anti-convulsants (e.g. gabapentin, pregabalin).
- •10. Dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
- •11. Steroids (oral, intra-muscular, intra-venous, intra-articular, epidural, or other corticosteroid injections) in the 6 weeks prior to Screening Visit or during the study.
- •12. No intra-articular hyaluron acid injection must be given 6 months prior to the Screening Visit and during the study.
- •13. Any joint evacuation must not be carried out before 6 weeks prior to Screening Visit and during the study.
- •14. Subjects, who are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 2 weeks before Screening.
- •15. Participation in a clinical research study involving a new chemical entity within 3 months of study entry.
- •16. Allergies or other contraindications to transdermal systems or patch adhesives.
- •17. Known tolerance and/or lack of effect of buprenorphine or tramadol.
- •18. Known hypersensitivity (allergic reaction) to opioids or Paracetamol.
- •19. Ongoing requirement for and treatment with direct external heat sources such as heat lamps, electric blankets, saunas, heating pads and heated waterbeds.
- •20. New physiotherapy regimen scheduled to commence during the Treatment Phase of the study.
- •21. Subjects, who cannot or will not cut the hair at the patch site for proper placement of the patch.
- •22. Any other contraindications listed in the Summary of Product Characteristics for Norspan® or Tiparol Retard®.
- •23. Subjects, who are unsuitable for any other reason to receive study medication in the opinion of the Investigator.
研究者
相似试验
进行中（未招募）
不适用
An open, randomized, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and lanthanum carbonate together with a randomized placebo controlled double blind fermagate comparison in hemodialysis patients with hyperphosphatemiaMedDRA version: 9.1Level: LLTClassification code 10020712Term: HyperphosphatemiaHyperphosphatemiaEUCTR2008-004729-41-DEINEOS Healthcare Limited820
进行中（未招募）
不适用
An open, randomized, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and lanthanum carbonate together with a randomized placebo controlled double blind fermagate comparison in hemodialysis patients with hyperphosphatemiaHyperphosphatemiaEUCTR2008-004729-41-FRINEOS Healthcare Limited820
进行中（未招募）
不适用
An open, randomized, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and lanthanum carbonate together with a randomized placebo controlled double blind fermagate comparison in hemodialysis patients with hyperphosphatemia. Estudio en fase III, abierto, aleatorizado, controlado y de grupos paralelos para investigar la seguridad y la eficacia de fermagato y carbonato de lantano, junto con una comparación con fermagato aleatorizada, doble ciego y controlada con placebo, en los pacientes en hemodiálisis con hiperfosfatemia.EUCTR2008-004729-41-ESINEOS Healthcare Limited820
进行中（未招募）
不适用
An open, randomised, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and sevelamer hydrochloride in haemodialysis patients with hyperphosphataemia.HyperphosphataemiaMedDRA version: 9.1Level: LLTClassification code 10020711Term: HyperphosphataemiaEUCTR2008-004730-25-BEINEOS Healthcare Limited780
进行中（未招募）
不适用
An open, randomised, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and sevelamer hydrochloride in haemodialysis patients with hyperphosphataemia.HyperphosphataemiaMedDRA version: 9.1Level: LLTClassification code 10020711Term: HyperphosphataemiaEUCTR2008-004730-25-SKINEOS Healthcare Limited780