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

Azienda Ospedaliera Universitaria
Policlinico Torvergata
Viale Oxford 81
Rome
00133
Italy

Study information

Study designObservational prospective longitudinal multicentre study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective observational study of the tolerability and efficacy of injectable hyaluronic acid therapy (Hyalubrix®) in osteoarthritis
Study acronymPEGASO
Study objectivesEvaluation 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) studiedOsteoarthritis
InterventionFour 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Hyalubrix®
Primary outcome measureAdverse 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 measures1. 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 date28/08/2006
Completion date12/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1300 Patients - 50 doctors
Key inclusion criteria1. 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 criteria1. 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 enrolment28/08/2006
Date of final enrolment12/01/2008

Locations

Countries of recruitment

  • Italy

Study participating centre

Azienda Ospedaliera Universitaria
Rome
00133
Italy

Sponsor information

Fidia Farmaceutici S.p.A. (Italy)
Industry

Via Ponte della Fabbrica 3/A
Abano Terme - Padova
35031
Italy

Email ngiordan@fidiapharma.it
Website http://www.fidiapharma.it
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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