Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Prot. Q47.2005.01
Study information
Scientific title
A prospective observational study of the tolerability and efficacy of injectable hyaluronic acid therapy (Hyalubrix®) in osteoarthritis
Acronym
PEGASO
Study hypothesis
Evaluation of the use of Hyalubrix®, under EC indications for registration, with particular reference to therapy tolerability.
Ethics approval
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)
Study design
Observational prospective longitudinal multicentre study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Hyalubrix®
Primary outcome measures
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 trial start date
28/08/2006
Overall trial end date
12/01/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1300 Patients - 50 doctors
Participant 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
Recruitment start date
28/08/2006
Recruitment end date
12/01/2008
Locations
Countries of recruitment
Italy
Trial participating centre
Azienda Ospedaliera Universitaria
Rome
00133
Italy
Sponsor information
Organisation
Fidia Farmaceutici S.p.A. (Italy)
Sponsor details
Via Ponte della Fabbrica 3/A
Abano Terme - Padova
35031
Italy
ngiordan@fidiapharma.it
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fidia Farmaceutici S.p.A. (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21407152
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21946401
Publication citations
-
Results
Foti C, Cisari C, Carda S, Giordan N, Rocco A, Frizziero A, Della Bella G, A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis., Eur J Phys Rehabil Med, 2011, 47, 3, 407-415.