Condition category
Musculoskeletal Diseases
Date applied
26/05/2009
Date assigned
21/07/2009
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Calogero Foti

ORCID ID

Contact details

Azienda Ospedaliera Universitaria
Policlinico Torvergata
Viale Oxford 81
Rome
00133
Italy

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

http://www.fidiapharma.it

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

  1. 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.

Additional files

Editorial Notes