The tolerability and efficacy of Hyalubrix® in osteoarthritis
| ISRCTN | ISRCTN42690497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42690497 |
| Secondary identifying numbers | Prot. Q47.2005.01 |
- Submission date
- 26/05/2009
- Registration date
- 21/07/2009
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Calogero Foti
Scientific
Scientific
Azienda Ospedaliera Universitaria
Policlinico Torvergata
Viale Oxford 81
Rome
00133
Italy
Study information
| Study design | Observational prospective longitudinal multicentre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective observational study of the tolerability and efficacy of injectable hyaluronic acid therapy (Hyalubrix®) in osteoarthritis |
| Study acronym | PEGASO |
| Study objectives | Evaluation of the use of Hyalubrix®, under EC indications for registration, with particular reference to therapy tolerability. |
| Ethics approval(s) | 1. Azienda Ospedaliera Universitaria Policlinico Tor Vergata approved on the 20th June 2006 2. Comitato Etico Novara approved on the 9th June 2006 (ref: 1069/CE). Final approval given on the 27th July 2006 (ref: 1127/CE) |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Four visits were scheduled: Visit one: enrolment and start of therapy Visit two: during study treatment Visit three: during study treatment Visit four: patient's final evaluation, 2 weeks from third injection At each visit, the following tools have also been adopted to evaluate the most significant effects of chronic pain on the social life and personality of the patient: 1. Pain at rest: Visual Analogue Scale (VAS) 2. Pain during motion: VAS 3. Functional Disability Index: Health Assessment Questionnaire (HAQ) 4. Quality of Life: EuroQoL |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hyalubrix® |
| Primary outcome measure | Adverse event notification. Timepoints: Visit 0: at baseline Visit 2: one week after baseline Visit 3: one week after visit 2 Final visit: two weeks after visit 3 |
| Secondary outcome measures | 1. Evaluation of the medical device performance on pain during motion and at rest, determined by VAS and HAQ 2. Quality of life evaluation (by means of EuroQoL) Timepoints: Visit 0: at baseline Visit 2: one week after baseline Visit 3: one week after visit 2 Final visit: two weeks after visit 3 |
| Overall study start date | 28/08/2006 |
| Completion date | 12/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1300 Patients - 50 doctors |
| Key inclusion criteria | 1. Patients suffering from degenerative or mechanical arthropathies who were candidates for being treated with Hyalubrix® 2. Patients aged 18 years or older, either sex 3. Patients who signed informed consent form |
| Key exclusion criteria | 1. Infections located in the body area to be treated 2. Established sensitivity to hyaluronic acid or to other components of the product |
| Date of first enrolment | 28/08/2006 |
| Date of final enrolment | 12/01/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Azienda Ospedaliera Universitaria
Rome
00133
Italy
00133
Italy
Sponsor information
Fidia Farmaceutici S.p.A. (Italy)
Industry
Industry
Via Ponte della Fabbrica 3/A
Abano Terme - Padova
35031
Italy
| ngiordan@fidiapharma.it | |
| Website | http://www.fidiapharma.it |
"ROR" |
https://ror.org/00dy5wm60 |
Funders
Funder type
Industry
Fidia Farmaceutici S.p.A. (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
