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.
- Conditions
- Acute sports-related traumatic blunt soft tissue injury/contusionMedDRA version: 12.1Level: LLTClassification code 10041738Term: Sports injury
- Registration Number
- EUCTR2009-018018-21-DE
- Lead Sponsor
- Reckitt Benckiser Healthcare UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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/contusion. (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 VAS (0-100mm)
viii)The absolute sensitivity to pain on the contralateral 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
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, 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 (Rest, Ice, Compression Elevation).
xxii)Anticipated poor compliance by the patient.
xxiii)Patients with a known sensitivity to any of the materials/ drug/ excipients in the patch respectively Paracetamol.
xxiv)Relevant consumption of alcohol 24 hours prior to randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the efficacy of a new ibuprofen patch versus placebo in the topical treatment of acute sports impact injuries/contusions.;Secondary Objective: The secondary objective will be to evaluate the tolerability of the patch in comparison to placebo.;Primary end point(s): The primary endpoint will be area under the VAS assessment of pain on movement curve over Days 0-3 (VAS AUC0-3d). The area under the curve will be calculated using the trapezoidal rule.
- Secondary Outcome Measures
Name Time Method