A multicentre, prospective, double-blind, in parallel groups randomised, versus placebo and versus reference product controlled, confirmatory clinical trial of the efficacy and tolerance of Flector Tissugel Héparine in the treatment of mild-to-moderate contusions.
- Conditions
- Muscle contusion with hematoma and pain of upper or lower limbs
- Registration Number
- EUCTR2005-003829-31-CZ
- Lead Sponsor
- IBSA, Institut Biochimique S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
• outpatients of both gender,
• age at least 18 and at most 65 years,
• Caucasian race,
• unilateral mild-to-moderate muscle contusion of upper or lower limbs that happened within 72 hours before the study entry,
• superficial haematoma of a maximal size of 10 x 14 cm, localised at the affected site,
• pain on standardised movement of at least 50 mm on a 100-mm visual analogue scale (VAS) ,
• injury does not need a orthopaedic or surgical treatment,
• 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 (see Section 7.4)
• female subjects of childbearing potential must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline (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 sign a written informed consent to the participation prior to inclusion in the study
• 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
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
• 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,
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method