跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2010-020748-37-SE
EUCTR2010-020748-37-SE进行中（未招募）不适用

An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee. - Norspan efficacy and safety among elderly subjects

Mundipharma AB0 个研究点开始时间: 2010年10月7日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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.Males and females aged 50-60 or = 75 years.
  • •2.Subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of ACR-criteria and radiographic evidence not older than one year.
  • •3.Subjects with a moderate to severe pain, confirmed by a BS-11 score = 4 for their pain on average during the Screening Phase in their primary OA-site at the Baseline Visit.
  • •4.Subjects must be willing to stop their current OA pain treatment and replace it with sponsor provided paracetamol with maximum tolerated daily dose intake during the Screening Phase (= 2000mg but = 4000mg daily).
  • •5.Female subjects of childbearing potential (including female subjects less than one year post-menopausal) must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective method 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 combined oral contraceptives, sterilization, implants, injectables, some IUDs (Intrauterine Device), or vasectomised partner.
  • •6.Subjects must 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 recording < 4 on average during the Screening Phase on the BS-11 scale.
  • •2.Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain.
  • •3.Subjects treated with a regular dose for > 1 week of tramadol, codeine or dextropropoxiphene within 1 month before screening visit.
  • •4.Subjects who require NSAID treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period.
  • •5.Subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
  • •6.Subjects scheduled for surgery that would fall within the study period.
  • •7.Subjects who currently abused substance or alcohol, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
  • •8.Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
  • •9.Untreated depression or other psychiatric disorder in such way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
  • •10.Subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the Investigator’s opinion, may pose a risk of additional CNS depression with study medication.
  • •11.Subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants.
  • •12.Dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
  • •13.Subjects who hade received an intra-articular steroid injection within 6 weeks prior Screening Visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period.
  • •14.Subjects with joint evacuation 6 weeks prior Screening Visit and during the study.
  • •15.Subjects who are currently taking monoamine oxidase inhibitors (MAOI’s) or have taken MAOI’s within 2 weeks before Screening Visit.
  • •16.Participation in a clinical research study involving a new chemical entity within 30 days before Screening Visit.
  • •17.Subjects with known tolerance and/or lack of effect of buprenorphine.
  • •18.Subjects with known allergy, hypersensitivity or other contraindications to opioids, transdermal delivery systems or patch adhesives.
  • •19.Ongoing requirement for and treatment with direct external heat sources such as heat lamps, electric blankets, saunas, heating pads and heated waterbeds.
  • •20.Subjects with new physiotherapy regimen scheduled to commence during Screening Phase or 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.
  • •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
Open-label, multi-center, two-stage, age stratified, pharmacokinetic, safety, and efficacy study in children 2 month to < 2 years of age undergoing Magnevist Injection enhanced MRI - Magnevist pediatric pharmacokinetic
EUCTR2009-013081-17-DEBayer HealthCare Pharmaceuticals, Inc.45
进行中（未招募）
不适用
Trial to examine ease-of-use of AMG504-1 administered in the home or school environments for treating hypoglycemia in children and adolescents with diabetesMedDRA version: 18.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 1 diabetes
EUCTR2015-003732-12-Outside-EU/EEAocemia Solutions ULC30
招募中
4 期
A post marketing surveillance study to evaluate safety and efficacy of fixed dose combination of Ceftriaxone + Sulbactam (Sulbactomax) in patients with various bacterial infections
CTRI/2012/04/002558Venus Remedies Limited2,500
进行中（未招募）
1 期
Abiraterone treatment for patients with relapsed ovarian cancer.
EUCTR2013-000293-29-GBThe Royal Marsden NHS Foundation Trust47
进行中（未招募）
不适用
A prospective, multicentre, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced / metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third lineAdvanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third lineMedDRA version: 17.1Level: PTClassification code 10033158Term: Ovarian epithelial cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2013-000491-14-ESAB Science56