mild-to-moderate contusions
Conditions
Interventions
Product Name: Flector Tissugel Héparine
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Heparin Sodium
CAS Number: 9041-08-1
Concentration unit: IU international unit(s)
Concentration type
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • outpatients of both gender, • aged between 18 and 65 years, • of Caucasian race, • having a unilateral mild-to-moderate muscle contusion of upper or lower limbs that happened within 72 hours before the study entry, • having a superficial haematoma of a maximal size of 10 x 14 cm, localised at the affected site, • with pain on standardised movement of at least 50 mm on a 100-mm visual analogue scale (VAS) , • whose injury does not need a orthopaedic or surgical treatment, whose injury does not need physiotherapy other than 3 daily ice applications of not more than 20 minutes duration for the first two days of treatment, if applicable, • female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the whole study period, • female subjects of childbearing potential must have a negative urine pregnancy test at screening/inclusion visit, • subjects must be able to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the Investigator, to comply with the requirements of the entire study and to return for the required examinations, • subjects must sign a written informed consent to the participation prior to inclusion in the study. 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
Exclusion criteria
Exclusion criteria: • A major injury (fracture, tear of ligament/muscle/cartilage, nerve injury), • Open skin lesion within the injured area, • History of three or more prior injuries (minor or major) to the actually injured region in the past, • Injury occurred more than 72 hours prior to study entry, • Injury is midline or involves the spine, • Haematoma is bigger than the size of one Tissugel plaster (10 x 14 cm), • Haematoma has a maximum diameter smaller than 4 cm, • Pain on movement <50 mm on a 100-mm Huskisson-type VAS, • Prior use of topical medication to involved area within 24 hours of study entry, • Prior use of OTC analgesic or NSAIDs (ibuprofen, ketoprofen) within 36 hours of study entry (acetaminophen permitted), • Prior use of narcotic analgesics within 7 days of study entry, • Prior use of systemic anti-inflammatory steroidal drugs, by any route of administration, within 60 days of study entry, • Prior use of long-acting NSAIDs such as piroxicam or naproxin since injury, • Concomitant use of drugs which may be susceptible to interactions with diclofenac or which may affect safety if used concomitantly (lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics), • Known hypersensitivity to diclofenac or other NSAID drugs (including aspirin), • Prior history of GI bleeds/ulcers, liver/kidney disease, • Patients with coagulation defects, • Patients with cardiac impairment, • Patients with allergic disorders, including asthma, • Pregnant women and women who are breast-feeding, • Patients participating or having been involved in other clinical investigations during the three months preceding the entry of this study, • Patients suffering from psychiatric diseases, not allowing the observance of the protocol, alcohol or drug abuse < 1 year, • Patients not able to understand the purposes of the study, • Patients refusing to give a written informed consent, • Patients not reliable, according to the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test if Flector Tissugel Héparine medicated plaster is significantly more effective as compared to the reference marketed product Flector Tissugel 1%, consisting in the same pharmaceutical form containing DHEP alone (without heparin) for the treatment of mild-to-moderate contusions.;Secondary Objective: To verify that both active formulations - test and reference - are significantly more effective as compared to a placebo Tissugel (same formulation but without active ingredients). Additional study objective is to evaluate the tested medications in terms of both local and general tolerance.;Primary end point(s): The primary efficacy parameter in this study is: Pain on movement: pain as perceived - and evaluated daily on a 100-mm Visual Analogue Scale (VAS) - by the patients, while performing a specific standardized movement, identified as the most painful movement to be done according to injured area location. The primary end point of the study is to demonstrate that Flector Tissugel Héparine medicated plaster is significantly more effective as compared to the reference marketed Flector Tissugel® 1% in terms of pain (on movement) reduction. | — |
Countries
Czech Republic, Germany
Outcome results
None listed