Symptomatic Hip OsteoarthritisPhase 3NCT00330135
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis
A Phase 3 study testing Sodium hyaluronate in people with Symptomatic Hip Osteoarthritis, run by Daiichi Sankyo at 1 site in France.
Trial summary
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Symptomatic Hip Osteoarthritis
- What is being tested?
- Sodium hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Primary osteoarthritis of the hip defined according to the ACR criteria; symptomatic, 2. Osteoarthritis of radiological grade II to III according to the Kellgren-Lawrence classification, using X-rays performed during the last three months, 3. Overall pain intensity between 40 and 80 mm on a VAS of 100 mm at the pre-screening examination, 4. The patients experienced pain at least one in two days during the last 30 days, it was resistant to paracetamol treatment at a dose of 4 g/day and a step 2 analgesic or a NSAID taken for at least 10 days, 5. A prosthesis is not planned in the next six months.
Who cannot join
- Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception,
- Major dysplasia (defined using Lequesne's criteria as dislocation of the hip),
- Treatment by intra-articular injection of hyaluronic acid in the symptomatic hip during the 6 months prior to pre-screening,
- Patients with a history of hypersensitivity to any of the ingredients in the hyaluronan,
- The presence of inflammatory arthropathy or another disorder or condition that could affect the joint (e.g., rheumatoid arthritis, metabolic bone disease, femoral head necrosis, psoriasis, gout, infection),
- Another muscular or skeletal condition that could interfere with the evaluation of the efficacy of the treatment on the hip in question (evaluation of pain or functional handicap),
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- Systemic corticosteroid therapy or intra-articular injection of corticosteroids into the ipsilateral hip or knee within the last month,
- Intermittent claudication or vascular disease,
- Previous surgery on the hip in question,
- Septic arthritis at any site,
- Any surgical procedure, including arthroplasty or arthroscopy, to the hip during the six months prior to pre-screening or surgery scheduled during the trial,
- Any chronic skin condition that could affect the site of the injection,
- Use of the investigational treatment or material during the last three months,
- Oral or injectable anticoagulant treatment,
- Antiaggregant platelet treatment, particularly low-dose aspirin,
- Symptomatic chondrocalcinosis in the painful hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.
Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.
At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).
- Conditions
- Symptomatic Hip Osteoarthritis
- Being tested
- Sodium hyaluronate, placebo injection
- Keywords
- hip osteoarthritis, Hyaluronic acid, Viscosupplementation, intra-articular injections
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronateDrug
Sodium hyaluronate 2.5 ml - 1 injection
placebo injectionDrug
placebo injection - 1 injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sodium hyaluronate 2.5 ml - 1 injection Receives: Drug: Sodium hyaluronate |
| 2 | Placebo comparator | Placebo injection - 1 injection Receives: Drug: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
Measured: 3 months
Secondary outcomes (4)
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Measured: 3 months
WOMAC index (the 3 subscales)
Measured: 3 months
Consumption of analgesics and NSAIDs
Measured: 3 months
Evaluation of tolerability (AE reporting)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xavier Chevalier, Professor, Principal investigator, Head of the department of rheumatology Hopital Henri Mondor, Creteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330135
- Sponsor's protocol ID
- ADA 2003-01
- Status last verified
- Jan 2008
- First submitted
- 23 May 2006
- Last updated
- 9 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazieres B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.
PubMed 19248105
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT00330135
- Acronym / sponsor ID
- ADA 2003-01
- Conditions
- Symptomatic Hip Osteoarthritis
- Keywords
- hip osteoarthritis, Hyaluronic acid, Viscosupplementation, intra-articular injections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.
Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.
At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sodium hyaluronateSodium hyaluronate 2.5 ml - 1 injection |
| 2 | Placebo comparator | Drug: placebo injectionPlacebo injection - 1 injection |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Primary osteoarthritis of the hip defined according to the ACR criteria; symptomatic, 2. Osteoarthritis of radiological grade II to III according to the Kellgren-Lawrence classification, using X-rays performed during the last three months, 3. Overall pain intensity between 40 and 80 mm on a VAS of 100 mm at the pre-screening examination, 4. The patients experienced pain at least one in two days during the last 30 days, it was resistant to paracetamol treatment at a dose of 4 g/day and a step 2 analgesic or a NSAID taken for at least 10 days, 5. A prosthesis is not planned in the next six months.
Key exclusion criteria (16 listed)
- Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception,
- Major dysplasia (defined using Lequesne's criteria as dislocation of the hip),
- Treatment by intra-articular injection of hyaluronic acid in the symptomatic hip during the 6 months prior to pre-screening,
- Patients with a history of hypersensitivity to any of the ingredients in the hyaluronan,
- The presence of inflammatory arthropathy or another disorder or condition that could affect the joint (e.g., rheumatoid arthritis, metabolic bone disease, femoral head necrosis, psoriasis, gout, infection),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hyaluronateSodium hyaluronate 2.5 ml - 1 injection | Drug | 1 |
| placebo injectionplacebo injection - 1 injection | Drug | 2 |
Primary outcome
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
Time frame: 3 months
4 secondary outcomes
Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)
Time frame: 3 months
WOMAC index (the 3 subscales)
Time frame: 3 months
Consumption of analgesics and NSAIDs
Time frame: 3 months
Evaluation of tolerability (AE reporting)
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2008.
- Derived from this study: PubMed 19248105Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazieres B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Chevalier, Professor principal investigator
Head of the department of rheumatology Hopital Henri Mondor, Creteil, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium hyaluronate in people with Symptomatic Hip Osteoarthritis, run by Daiichi Sankyo at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2008.