E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 |
Primary objective of this trial is to evaluate, after 28 days from the beginning of therapy, the efficacy of the infiltrative treatment with hyaluronic acid versus saline solution on pain and physical function, using the VISA-A questionnaire, in patients with subacute or chronic tendinitis of Achilles tendon |
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E.2.2 | Secondary objectives of the trial |
For the double-blinded phase, secondary objectives are:
-improvement of clinical disease profile
-reduction of pain
-improvement of ultrasound results
-satisfaction of patient and medical judgment
-consumption of anti-inflammatory drugs
-local and systemic tolerance of the therapy
for the open-label extension, the same objectives will be evaluated, considering the treatment received. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-aged 18 to 70 included
-diagnosis of chronic (syntoms persisting for over 6 weeks) or subacute (syntoms persisting approximately 3-6 weeks) tendinitis of Achilles tendon, diagnosed clinically or/and by means of ultrasound.
-presence of at least one of the following parameters:
- thickening of tendon
- increased thermotouch,
- pain to palpation and pressure,
- VAS ≥ 40 mm
- Limited range of motion;
-Total score VISA-A inclusion of less than 60;
-signing of informed consent form |
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E.4 | Principal exclusion criteria |
- Tendonitis in acute inflammatory phase (symptoms present for less than 3 weeks);
- Patients with lateral instability of the ankle;
- Obese patients with BMI> 35 kg/m2;
- History of diabetes mellitus or any other disease which, in the opinion of the investigator, would be able to influence the detection of experimental data;
- History of arthritic diseases and / or metabolic disorders;
- suspected (based on clinical judgment or tests) structural tendon lacerations (previous or current);
- serious previous trauma to the Achilles tendon;
- Patients with bilateral Achilles tendinopathy.
- Patient undergone previous surgery to the Achilles tendon under study or its ankle;
- Use of corticosteroids and fluoroquinolones for oral, parenteral or intra-articular in the three months prior to inclusion in the study;
- injection of hyaluronic acid in the Achilles tendon under evaluation in the three months prior to inclusion in the study;
- Patient pregnant;
- Participation in other clinical trials in the three months prior to inclusion in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint for efficacy is the assessment of pain and physical function using the VISA-A questionnaire. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 28 days from the first injection |
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E.5.2 | Secondary end point(s) |
Secondary endpoints:
Clinical Evaluation: joint movement, ability to walk on their toes and rise up on their toes standing on one foot;
Ultrasound assessment: the tendon thickness and disappearance of signs of inflammation (edema, flogosis and tendinosis)
Evaluation of the reduction of pain by VAS
consumption of Paracetamolo in terms of days of intake;
satisfaction of patient and medical judgment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
double blinded study with open label extension |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | |
E.8.9.1 | In the Member State concerned days | |