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

• Conditions: Acute pain in soft-tissue injuries of lower limbs, except toes

• Registration Number: EUCTR2004-000909-22-ES
• Lead Sponsor: MDS Pharma Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

- 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

- Use of:
.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.

Study & Design

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