Acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbs MedDRA version: 16.1 Level: LLT Classification code 10031585 Term: Other and unspecified injury to unspecified site System Organ Class: 100000004863
Conditions
Interventions
Product Name: Nurofen topical patch
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Ibuprofen
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Reckitt Benckiser Healthcare (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: a) at Hour 48 b), d), f), h) and i) at every visit j) and k) at Visit 7, 9 and 11 c) over 0-12 hours, 0-24 hours, 0-48 hours and 0-120 hours e) and g) over 0-24 hours, 0-48 hours, 0-72 hours and 0-120 hours;Secondary end point(s): A key secondary endpoint will be a) the VAS assessment of pain on movement at Hour 48. Further secondary endpoints are: b) VAS assessment of pain on movement at each assessment other than Hour 48. c) Area under the VAS assessment of pain on movement curve over 0-12 hours, 0-24 hours, 0-48 hours and 0-120 hours d) Tenderness/algometry (pressure required to produce the first tenderness reaction) at each assessment. e) Area under the tenderness/algometry curve from over 0-24 hours, 0-48 hours, 0-72 hours and 0-120 hours f) The ratio (injured / contralateral site) tenderness/algometry assessment at each assessment. g) Area under the ratio (injured / contralateral site) tenderness/algometry curve over 0-24 hours, 0-48 hours, 0-72 hours and 0-120 hours h) The time taken to reach the contralateral (healthy) values of tenderness (time to resolution of pain). i) Use of rescue medication and time of use of rescue medication. j) Global assessment of treatment efficacy by patients and Investigators using a 5-point scale (4 = excellent, 3 = good, 2 = fair, 1 = poor, and 0 = none). Assessments will be made on Assessment Days 1 (Visit 7), 3 (Visit 9) and 5 (Final Visit). k)Safety – will be evaluated by monitoring general physical examinations, vital signs as well as the occurrence of adverse events. In addition, patients and Investigators will make a global assessment of local tolerability of the patch under double-blind conditions using a 4-point scale (3 = excellent, 2 = good, 1 = fair, and 0 = poor) assessments will be made on Assessment Days 1 (Visit 7), 3 (Visit 9) and 5 (Final Visit). | — |
Countries
Germany
Contacts
Public ContactFachgebiet Klinische Prüfung
Bundesinstitut für Arzneimittel und Medizinprodukte
Outcome results
None listed