Clinical 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
- Conditions
- Acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbsMedDRA version: 16.1Level: LLTClassification code 10031585Term: Other and unspecified injury to unspecified siteSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-003257-29-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
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
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.
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): Area under the VAS assessment of pain on movement curve over 0-72 hours;Timepoint(s) of evaluation of this end point: Over 0-72 hours
- Secondary Outcome Measures
Name Time Method