E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000433 |
|
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 the study is to evaluate, using the VISA-A questionnaire, the efficacy of hyaluronic acid infiltration therapy in pain and physical activity in patients with subacute or chronic tendinitis of the Achilles tendon. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives consist in evaluating the following: - efficacy of the therapy in improving the clinical profile of the disease; - efficacy of the therapy in improving ultrasound results (thickness of tendon, presence of edema, of tendinosis and signs of phlogosis); - efficacy of the therapy in terms of patient satisfaction and medical judgment ; - anti-inflammatory drugs consumption; - local and systemic tolerance of the therapy. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Aged 18 to 70 years, inclusive; - Diagnosis of chronic (symptoms persisting for over 6 weeks) or subacute (symptoms persisting for approximately 3-6 weeks) tendinitis of the Achilles tendon, diagnosed clinically and/or by means of ultrasound; - Pain in the Achilles tendon at rest or after moderate physical activity; - Presence of at least one of the following parameters: swelling of the tendon, increase in local temperature (to the touch), pain upon touching or applying pressure, limited range of joint motion; - Total score on VISA-A less than 60; - Non responder to traditional tendinitis therapy: anti-inflammatory and/or physical therapy; - Non-responder to abstinence from the physical activity causing pain to the Achilles tendon; - Signing of informed consent. |
|
E.4 | Principal exclusion criteria |
- Tendinitis in acute inflammatory phase; - Lateral instability of the ankle; - Obesity: BMI >35 kg/m2; - Bilateral tendinitis; - History of diabetes mellitus or any other disease which in the Investigator`s opinion might influence the experimental data; - Presence of areas of degeneration in the tendon (tendinosis); - History of arthritic and/or metabolic disease; - Suspected (based on clinical judgement or tests) structural lesions of the tendon (previous or current); - Previous major trauma to the Achilles tendon; - Previous surgery on the Achilles tendon under evaluation or on the same ankle; - Oral, parenteral or intra-articular use of corticosteroids during the three months previous to enrolment in the study; - Infiltration therapy with hyaluronic acid on the Achilles tendon under evaluation during the three months previous to enrolment in the study; - Para-tendinopathy; - Pregnancy; - Participation in other clinical trials during the three months previous to enrolment in the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for efficacy evaluation is the assessment of pain and physical activity using the VISA-A questionnaire. |
|
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 12 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |