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 Heparine in the treatment of ankle sprains. - ND

• Conditions: ankle sprains; MedDRA version: 9.1Level: LLTClassification code 10023229Term: Joint sprain

• Registration Number: EUCTR2006-003773-28-IT
• Lead Sponsor: IBSA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Outpatients of both gender, aged between 18 and 65 years, having an acute ankle sprain involving the lateral ligaments i.e. inversion mechanism , occurred during the 48 hours preceding inclusion in the study, with presence of peri-malleolar oedema difference between the sub-malleolar perimeter of injured and healthy ankle of at least 20 mm, when measured by means of a measuring tape and with pain on movement while performing normal daily activities 8805; 50 mm on a 100-mm VAS, without any previous treatment, will be included in the study, after having given their written informed consent to participation. Sprain must be benign in nature grade I or II according to the annexed classification and not requiring an orthopaedic or surgical treatment in case of doubt, a radiographic evaluation according to the Ottawa criteria will be done , nor a physiotherapeutic treatment other than standardised ice/cold packs application see section 5.2 . Anyway, the recourse to ice/cold packs applications will not be permitted during the study period.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 and they must have a negative urine pregnancy test at screening/inclusion visit.
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

Major reasons for exclusion are presence of an open skin lesion within the injured area, presence of any dermatological condition affecting the site of plaster application, three or more prior injuries to the actually injured ankle in the past, relapsing sprains already treated during the 6 months preceding the study, prior use of any topical medication to involved area or prior use of OTC analgesic or NSAIDs ibuprofen, ketoprofen within 48 hours before study entry acetaminophen permitted , prior use of narcotic analgesics within 7 days before study entry, prior use of systemic anti-inflammatory steroidal drugs by any route of administration within 60 days preceding study entry, prior use of long-acting NSAIDs such as piroxicam or naproxene since injury, concomitant use of drugs which may be susceptible of interactions with diclofenac or which may affect safety if used concomitantly lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs and diuretics , patients with severe grade III ankle sprain or with sprain suggesting associated lesions, with acquired or congenital hyperlaxity, with history of dislocation or fracture or other diseases affecting the injured joint, or with surgery to the affected joint dated less than one year, patients with coagulation defects, with cardiac impairment, history of GI bleeds/ulcers or liver/kidney disease, known hypersensitivity to diclofenac or other NSAID drugs including aspirin or to paracetamol rescue medication , pregnant and breast-feeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objective of the study is 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 end point of the study is to demonstrate that Flector Tissugel He parine medicated plaster is significantly more effective as compared to the reference marketed Flector Tissugel 1 in terms of pain on movement reduction.;Main Objective: The primary objective of the study is to test if Flector Tissugel He parine 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 ankle sprains.