E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Painful and traumatic inflammation of the joints, muscles, tendons and ligaments. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10028393 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10023213 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10043237 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10028302 |
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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 |
The primary objective of this study is to evaluate the subjective response to the treatment with the formulation of diclofenac gel 1% in reducing pain as self-measured by using a 10 points graduate VAS scale. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are: • To evaluate the the effectiveness of the formulation of diclofenac gel 1% in reducing pain as measured at centre by using a VAS scale. • To evaluate the tolerability and safety of formulation of diclofenac gel 1% recording the incidence of local and overall adverse events, and vital signs (heart rate and blood pressure). Blood samples will be collected to monitor blood levels of diclofenac for safety purpose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects willing and able to understand and sign an approved informed consent form; 2. Provision of written informed consent; 3. Subjects of either gender and aged 18-65 years: 4. Subjects with traumatic disease of the joints, muscles, tendons and ligaments; 5. If female and of child-bearing potential, the patient must be non-nursing and practicing an effective method of contraception throughout the study duration. All females of child-bearing potential must have a negative serum or urine pregnancy test prior the first administration. |
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E.4 | Principal exclusion criteria |
1. Subjects unwilling to give an approved informed consent form; 2. Subjects with known osteo-musculo-articular lesions; 3. Female of child-bearing potential and lactating; 4. Presence of dermatological diseases in the area of application; 5. Treatment with any NSAID or drug containing diclofenac; 6. History of alcohol or drug abuse; 7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; 8. Subjects who, for whatever reason are unlikely to comply with study requirements; 9. Subjects who have received any investigational drug and/or non-approved drug within 12 weeks before the study entry; 10. Subjects who were previously enrolled in this study; 11. Employees of the centre (i.e. principal investigator, co-investigator, study coordinator, other staff member, and employees) with direct involvement in the study or other studies conducted or directed by the investigator in the centre, as well as relatives of employees or of the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable of this study is the response to treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |