Comparative efficacy and tolerability of a topical ketoprofen TDS patch vs ketoprofen gel in the treatment of acute pain in soft-tissue injuries

MDS Pharma Services0 个研究点目标入组 240 人开始时间: 2004年6月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male or female patients aged 18 to 70 years
•2. Diagnosis of painful soft tissue injury of lower limbs ( sprains, strains and contusions)except toes of recent onset (less than 48 hours)
•3. Spontaneous pain at rest = 35 mm on the Huskisson's 100-mm VAS
•4. Females of child-bearing potential must be:
•- surgically incapable of pregnancy, or
•- practising an acceptable method of birth control (i.e. oral hormonal contraceptives or Intrauterine Device)
•5. Understanding of the study and agreement to give a written informed consent,
•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) yes
•F.1.3.1 Number of subjects for this age range

•- Patients with an open lesion or serious injury, including a fracture, nerve injury and a tear of ligament, muscle or cartilage
•- Painful soft tissue injury associated with osteoarthritis or rheumatoid arthritis,
•- Painful soft tissue injury requiring orthopaedic or surgical treatment (except elastic bandage),
•- Contraindications to ketoprofen or any NSAID
•- Known hypersensitivity to ketoprofen or to any other component of the patch or gel formulation, or any NSAID
•- Contraindication to paracetamol or to any of the ingredients of the supplied rescue medication,
•- Known hypersensitivity to paracetamol or any other component of the supplied rescue medication
•.paracetamol within 12 hours before the inclusion
•.aspirin or NSAIDs within 12 hours before the inclusion
•. topical medications applied to the painful region since the injury
•.opioids within 7 days before the inclusion
•.corticosteroid drugs by any route of administration within 30 days before the inclusion
•.any physical therapy (physiotherapy and kinesis-therapy) within 24 hours before the inclusion (except cold application)
•.any investigational drugs in the last 30 days prior to inclusion.
•- Skin conditions affecting the site of application (wound, eczema, weeping dermatitis…).
•- Patients suspected to have a high potential for non-compliance to the study procedures and/or of non-completion of the study for non-medical reasons, according to the Investigator’s judgement.

发起方

MDS Pharma Services