The tolerability and efficacy of Hyalubrix® in osteoarthritis

ISRCTN	ISRCTN42690497
DOI	https://doi.org/10.1186/ISRCTN42690497
Protocol serial number	Prot. Q47.2005.01
Sponsor	Fidia Farmaceutici S.p.A. (Italy)
Funder	Fidia Farmaceutici S.p.A. (Italy)

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

Azienda Ospedaliera Universitaria
Policlinico Torvergata
Viale Oxford 81
Rome
00133
Italy

Study information

Primary study design	Observational
Study design	Observational prospective longitudinal multicentre study
Secondary study design	Cross-section survey
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hyalubrix®
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	12/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1300
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes