Contact information
Type
Scientific
Primary contact
Prof Alberto Migliore
ORCID ID
Contact details
Ospedale San Pietro FBF
Via Cassia
600
Rome
00189
Italy
albertomigliore@terra.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Q47-04-01
Study information
Scientific title
Comparative, double blind, controlled study of intra-articular hyaluronic acid (Hyalubrix®) injections versus local anaesthetic in osteoarthritis of the hip
Acronym
Study hypothesis
The study compared the benefit, duration and adverse event profile of intra-articular (IA) Hyalubrix® versus IA mepivacaine in the treatment of hip osteoarthritis (OA) using ultrasound-guidance to ensure IA injection.
Ethics approval
The Clinical Study Protocol (CSP) with all its appendices, including informed consent documentation, insurance and Summary of Product Characteristics were submitted for evaluation and approval to the competent Ethic Committee in the involved centre. The study received the favourable opinion by the Ethic Committee on the 9th November 2004.
Study design
Single-site prospective randomised double-blind controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Nicola Giordan at ngiordan@fidiapharma.it to request a patient information sheet
Condition
Hip osteoarthritis
Intervention
IA hip injections were guided by ultrasound using an anterosagittal in assistance of real-time ultrasound and Doppler imaging:
Active group: IA injection of Hyalubrix® 4 ml (2 syringes, 60 mg)
Control group: Mepivacaine 4 cc of 2%
Two treatment administrations: one at baseline, and the second one after one month.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hyalubrix®, mepivacaine
Primary outcome measure
Determination of the change in the Lequesne index of the hip, comparing IA Hyalubrix® to IA mepivacaine at 26 weeks.
Secondary outcome measures
Measured 90 and 180 days after first injection:
1. Pain intensity (recorded on a 10 cm VAS)
2. Patient record of non-steroidal anti-inflammatory drug (NSAID) consumption
3. Patients global assessment
4. Examining physician's global assessment
5. Demographic correlations to response
6. Hyaluronic acid (HA) safety
Overall trial start date
09/11/2004
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 40 years, either sex
2. Ambulant without assistance
3. Hip OA by American College of Rheumatology (ACR) radiographic criteria
4. Baseline Visual Analogue Scale (VAS) score of greater than 4 cm
5. Persistence of hip pain for at least 1 month before baseline
6. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 participants (20 patients for arm)
Participant exclusion criteria
1. Comorbidities (e.g. rheumatoid arthritis, avascular necrosis, fibromyalgia)
2. Infection around the injection site
3. Treatment with oral, parenteral, or IA steroids within 3 months
4. Use of anticoagulants or history of thrombocytopaenia
5. Allergy to local anaesthetics
6. History of adverse reaction to IA Hyalubrix®
7. Pending hip replacement surgery
8. Use of a purported OA disease modifying agent
Recruitment start date
09/11/2004
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Ospedale San Pietro FBF
Rome
00189
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
Basic results (scientific)
Publication list