E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute pain in soft-tissue injuries of lower limbs, except toes |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the overall clinical efficacy and safety of ketoprofen TDS patch versus Ketoprofen gel in the treatment of acute pain related to soft-tissue injuries of lower limbs except toes (ankle and knee sprains, strains and contusions) |
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E.2.2 | Secondary objectives of the trial |
1. To compare the two treatments in terms of
- pain at daily activities intensity improvement - overall change in clinical condition - onset of analgesic effect after the first application of topical treatment - change in quality of sleep, pain intensity, pain relief, symptoms at injury (swelling, stiffness and bruise) site and use of rescue medication (paracetamol consumption) - of global evaluation of the therapy (assessed by the investigator), and in terms of overall judgement of the efficacy and tolerability (assessed by the patient) - of tolerability, based on the assessment and the recording of the adverse events (AEs) up to 7 days after the last patch application, and physical examination - judgment on treatment acceptability and convenience (assessed by the patient)
and
2. to investigate possible connections between response to treatment and baseline characteristics of patients included.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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,
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess spontaneous pain at rest during the last 24 hours, at visit 2 from baseline |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |