EUCTR2011-003890-27-DE进行中（未招募）不适用
A multi-centre, double-blind, randomised, parallel group study to assess the efficacy and safety of multiple doses of topically applied hyperemisation-inducing ointment (2 cm ointment line per application; up to 3 times daily for up to 4 days) containing 2.5% Nicoboxil/0.4% Nonivamide versus 2.5% Nicoboxil, 0.4% Nonivamide and placebo in patients 18 to 65 years of age with acute low back painIII
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
- •-Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and local regulation prior to participation in the trial.
- •-Patients must agree to cooperate with all trial evaluations and perform all required tasks.
- •-Acute low back pain for more than 2 days and less than 21 days (= 3 weeks)
- •-Male or female patients aged 18 to 65 years
- •-Low back pain rating >= (above or equal to) 5 on a 0-10 numerical rating scale (NRS).
- •-Negative urine pregnancy test for female patients of child-bearing potential
- •-Women of childbearing potential using a highly effective method of birth control.
- •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 760
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Multilocular pain or panalgesia.
- •- History of more than three low back pain episodes in the last six months.
- •- Abnormal findings in at least one of the following assessments: Achilles tendon reflex, patella reflex, heel walking, toe walking, cutaneous sensitivity of the legs (including gluteal region), paresis tests in supine position upon dorsiflexion, plantarflexion, hip flexion, knee extension.
- •- Bladder and/or rectum dysfunction.
- •- Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), traumatic, or infective origins.
- •- Any condition, disease or concomitant treatment that in the judgement of the Investigator will affect the subject's ability to participate in the clinical trial or which will influence the test methodology used.
- •- Negative experience in the past with heat treatment for muscle complaints (e. g. hot water bottle, heat pads, hyperemisation-inducing topical creams, ointments or patches).
- •- History of treatment of back pain with centrally acting analgesics (e. g. opioids) and muscle relaxants.
- •- Surgery due to back pain or rehabilitation due to back pain in the last 12 months.
- •- Spinal injection back pain treatment within 6 months prior to enrollment.
- •- Intake of antidepressant/antipsychotic medication within 4 weeks prior to enrollment.
- •- Treatment of the recent low back pain period with oral analgesics for more than 4 consecutive days.
- •- Locally applied medication to the back within 48 hours prior to enrollment (topical treatments, injections).
- •- Administration of other analgesics within 24 h prior to enrollment (exception: acetyl salicylic acid (ASS) up to 100 mg/daily for anti platelet-aggregation therapy).
- •- Non-pharmacological low back pain treatment (physiotherapy, heat treatment (e.g. hot water bottle, heat patch), or massages within 12 h prior to enrollment.
- •- Participation in an investigational drug or device trial within 4 weeks prior to enrollment
- •- Hypersensitivity to Nicoboxil, Nonivamide, or paracetamol.
- •- Skin lesions (e. g., rash, dermatitis, bruising, laceration) in the back region.
- •- Drug dependence and/or alcohol abuse.
- •- Severe hepatocellular insufficiency.
- •- Patients who are pregnant or breast-feeding.
研究者
相似试验
已完成
不适用
A multicentre, double-blind, randomised, parallel group, placebo-controlled trial of LAX-101 (ethyl eicosapentaenoate [EPA]) in patients with a new or recurrent episode of depressioDepressionMental and Behavioural DisordersDepressive episodeISRCTN63565713axdale Ltd (UK)
已完成
不适用
A multicentre, double-blind, randomised, parallel group, placebo-controlled, dose ranging pilot study of ethyl eicosapentaenoate (EPA) as adjunct therapy in patients who remain depressed following treatment with standard antidepressant therapyDepressionMental and Behavioural DisordersISRCTN44366049axdale Ltd (UK)
已完成
不适用
A multicentre, double-blind, randomised, parallel group, placebo-controlled, dose-ranging pilot study of ethyl-eicosapentaenoate (ethyl-EPA) in patients with schizophreniaMental and Behavioural DisordersSchizophreniaISRCTN44218911axdale Ltd (UK)
已完成
不适用
A multicentre, double-blind, randomised, parallel group, placebo-controlled trial of LAX-101 (ethyl eicosapentaenoate [EPA]) as adjunct therapy in patients who remain depressed following treatment with standard antidepressant therapyDepressionMental and Behavioural DisordersDepressive episodeISRCTN38354847axdale Ltd (UK)
进行中（未招募）
不适用
A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared to Daivobet® and vehicle in the treatment of adult patients with chronic stable plaque psoriasisChronic stable plaque psoriasis.MedDRA version: 17.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2013-002861-20-PLek Pharmaceuticals d.d.411