EUCTR2012-003257-29-DE进行中（未招募）不适用
A randomised, double-blind, multi-centre, placebo controlled parallel group study to evaluate the efficacy and tolerability of a new Ibuprofen patch in patients with acute sports related traumatic blunt soft tissue injury/contusion to the upper or lower limbs - Nurofen topical patch efficacy study
Reckitt Benckiser Healthcare (UK)0 个研究点开始时间: 2012年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Age: 18-60
- •2. Sex: male or female
- •3. Normal general health.
- •4. Primary diagnosis: acute sports-related blunt soft tissue injury/contusion (time elapse between traumatic event and first treatment not longer than 3 hours) which are close to a joint of the upper or lower limb.
- •5. Injury not requiring hospitalisation.
- •6. The basic value of the algometric measurement on the injured site is less than or equal to 50% of the respective value at the contralateral site.
- •7. Pain on movement at baseline at least 65 mm on a VAS (0-100 mm).
- •8. The absolute sensitivity to pain on the contralateral site is at least 25 N/cm2.
- •9. Written informed consent.
- •10. The size of the traumatisation must be at least 25 cm2 and maximal 120 cm2.
- •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 132
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •i) History of blood coagulation disorders.
- •ii) A history of significant disease deemed by the Investigator to render the patient unsuitable for inclusion.
- •iii) Any significant ongoing painful condition other than that associated with the sports related injury/contusion.
- •iv) Any other treatment or medication that may interfere with the trial (e.g. corticosteroids) up to 3 days prior to the trial, except RICE (Rest, Ice, Compression and Elevation).
- •v) Any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication.
- •vi) A history of psychotic illness, attempted suicide, or neurosis.
- •vii) A positive history of drug or alcohol abuse within the past year.
- •viii) Those taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative –hypnotics taken within fives times of their elimination half lives.
- •Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) are permitted if the patient has been on a stable dose for at least four weeks prior to Visit 1 (screening) and remain on this dose throughout the study.
- •ix)Patients, to whom contraindications, warnings and restrictions of use mentioned in the SmPC of Paracetamol apply including for example (but not limited to) impairment of the hepatic function, renal insufficiency
- •x)Those taking medication with a known potential interaction with Paracetamol according to the related SmPC including for example (but not limited to) gout medication, salicylamide and metoclopramide
- •xi) Any other treatment or medication, that interferes with the conduct of the trial, except RICE (Rest, Ice, Compression and Elevation).
- •xii) Female Patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions (as defined in Section 9.3 of the protocol) or are unwilling to be sexually abstinent
- •xiii) Pregnancy or lactating mother.
- •xiv) Any previous history of allergy or known intolerance to any of the drugs or formulation constituents which, in the Investigator’s opinion, might preclude use of an NSAID, including aspirin sensitive asthma or a previous allergic response to a NSAID, including bronchospasm, urticaria, angioedema and rhinitis.
- •xv) Those previously randomised into this study.
- •xvi) Patients who have received any analgesic, anti-inflammatory, antispasmodic or other therapy (except RICE) within 24 hours prior to application of the study medication.
- •xvii) Those who have participated in a clinical trial in the previous 30 days calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial.
- •xviii) Injured area is too hairy.
- •xix) Current skin disorders in the area to be treated.
- •xx) Open wounds to the area to be treated.
- •xxi) Suspected fractures.
- •xxii) Suspected torn ligaments.
- •xxiii) Head injuries.
- •xxiv) Pre-treatment of injury (any other therapy, except RICE (Rest, Ice, Compression and Elevation).
- •xxv)Anticipated poor compliance by the patient.
- •xxvi)Patients with a known sensitivity to any of the materials/ drug/excipients in the patch respectively Paracetamol.
- •xxvii)Relevant consumption of alcohol 24 hours prior to randomisation
- •xxviii) Employee at study site.
- •xxix) Partner or first-degree relative of the Investigator.
- •xxx) Unable in the opinion of the Investigator to comply fully with the study requirements.
研究者
相似试验
进行中（未招募）
1 期
A randomised, double-blind, multi-centre, placebo controlled parallel group study to evaluate the efficacy and tolerability of a new Ibuprofen gel in patients with acute sports-related traumatic blunt soft tissue injury/contusion. - Project BRONSON efficacy trial.EUCTR2009-018017-40-DEReckitt Benckiser Healthcare UK Ltd
进行中（未招募）
不适用
A randomised, double-blind, multi-centre, placebo controlled parallel group study to evaluate the efficacy and tolerability of a new Ibuprofen patch in patients with acute sports related traumatic blunt soft tissue injury/contusion.Acute sports-related traumatic blunt soft tissue injury/contusionMedDRA version: 12.1Level: LLTClassification code 10041738Term: Sports injuryEUCTR2009-018018-21-DEReckitt Benckiser Healthcare UK
进行中（未招募）
1 期
A randomized, double-blind, multi-centre, placebo controlled phase II clinical study to evaluate the efficacy, tolerance and safety of an aqueous gel containing 2% (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3) - Colvir-Phase IIHigh Grade of Cervical Intraepithelial Neoplasia (CIN).MedDRA version: 14.1Level: LLTClassification code 10007494Term: Carcinoma uterine cervix in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023271-26-BEMithra Pharmaceuticals SA
进行中（未招募）
不适用
A study to learn more about the effects of a pain relief medicine called methoxyflurane (known as Penthrox(TM)) on pain caused by a minor injury. The effects will be compared to a dummy medicineAcute painMedDRA version: 14.0Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 10018065 - General disorders and administration site conditionsEUCTR2011-000338-12-GBMedical Developments International Limited300
进行中（未招募）
4 期
Aspirin for the prevention of cognitive decline in the Elderly: a Neuro-Vascular Imaging Study (ENVIS-ion), a sub-study of ASPirin in Reducing Events in the Elderly (ASPREE)ACTRN12609000613202Australian National University (ANU)600