EUCTR2009-018017-40-DE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.
试验速览
- 阶段
- 1 期
- 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
- •Only Patients to whom all of the following conditions apply will be randomised:
- •i) Age: 18-60 years
- •ii) Sex: Both male or female patients may be included.
- •iii) Normal general health
- •iv) Primary diagnosis: fresh sports-related blunt soft tissue injury. (Time elapse between traumatic event and inclusion not longer than 3 hours).
- •v) Injury not requiring hospitalisation.
- •vi) 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.
- •vii) Pain on movement at baseline at least 50mm on a 100mm VAS.
- •viii) The absolute sensitivity to pain on the contra lateral site is at least 2.5 N/cm2.
- •ix) Written informed consent.
- •x) The size of the traumatisation must be at least 25cm2 and maximal 150cm2.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients to whom any of the following conditions apply must not be randomised:
- •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.
- •iv) Any other treatment or medication that my interfere with the trial (e.g. corticosteroids) up to 3 days prior to the trial, except RICE (Rest, Ice, Compression, 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) Any other treatment or medication, that interferes with the conduct of the trial, except RICE (Rest, Ice, Compression, Elevation).
- •x) Women of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the patient become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- •xi) 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.
- •xii) Those previously randomised into this study.
- •xiii) Patients who have received any analgesic, anti-inflammatory, antispasmodic or other therapy (except RICE) within 24 hours of taking the study medication.
- •xiv) 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.
- •xv) Injured area is too hairy.
- •xvi) Current skin disorders in the area to be treated.
- •xvii) Open wounds to the area to be treated.
- •xviii) Suspected fractures.
- •xix) Suspected torn ligaments.
- •xx) Head injuries.
- •xxi) Pre-treatment of injury (any other therapy, except RICE).
- •xxii) Anticipated poor compliance by the patient.
- •xxiii) Patients with a known sensitivity to any of the materials/ drug/excipients in the gel respectively Paracetamol.
- •xxiv) Relevant consumption of alcohol in the 24 hours prior to randomisation.
研究者
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