OsteoarthritisPhase 3NCT00171652
Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
A Phase 3 study testing Diclofenac sodium gel 1% in people with Osteoarthritis, run by Novartis at 48 sites in 2 countries.
Trial summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diclofenac sodium gel 1%
- How many people
- 360 participants
- Where
- 48 sitesin 2 countries
- Study dates
- May 2005to Oct 2005
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the hand
Who cannot join
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
Germany31 sites
Study site
Bad Hersfeld, 36251
Study site
Bad Nauheim, 61231
Study site
Berlin, 10589
Study site
Berlin, 10711
Study site
Berlin, 10961
Study site
Berlin, 12247
Study site
Berlin, 13125
Study site
Berlin, 13581
Study site
Berlin, 14163
Study site
Bochum, 44789
Study site
Dinslaken, 46535
Study site
Dortmund, 44263
Study site
Dreieich, 63303
Study site
Dresden, 01129
Study site
Frankfurt a/M, 60433
Study site
Hagen, 58099
Study site
Hamburg, 20249
Study site
Hamburg, 20357
Study site
Hamburg, 22143
Study site
Hamburg, 22767
Study site
Karlsruhe, 76133
Study site
Kassel, 34123
Study site
Leipzig, 04109
Study site
Ludwigshafen, 67069
Study site
München, 80333
Study site
München, 80339
Study site
München, 80538
Study site
München, 80798
Study site
Neustadt/Aisch, 91413
Study site
Nuremberg, 90441
Study site
Stuttgart, 70178
France17 sites
Study site
Cergy, 95000
Study site
Clamart, 92140
Study site
Cournonterral, 34660
Study site
Fellering, 68470
Study site
Goussonville, 78930
Study site
Linas, 91310
Study site
Longpont-sur-Orge, 91310
Study site
Meaux, 77100
Study site
Nantes, 44000
Study site
Orly, 94310
Study site
Paris, 75010
Study site
Paris, 75011
Study site
Paris, 75015
Study site
Paris, 75020
Study site
Savigny-sur-Orge, 91600
Study site
Thouars, 79100
Study site
Villeneuve-le-Roi, 94290
About this study
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Diclofenac sodium gel 1%
- Keywords
- Hand osteoarthritis, Topical NSAID, Diclofenac sodium
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodium gel 1%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
OA pain intensity in target hand at Week 4 and 6
Total AUSCAN score in target hand at Week 4 and 6
Global rating of disease activity by patient at Week 4 and 6
Secondary outcomes (5)
OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8
OA pain intensity in target hand and use of rescue medication recorded in diary
Global evaluation of treatment at final visit
Treatment responder rate according to OARSI criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Study completionOct 2005
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 OsteoarthritisStudies of the same condition, open and under way.
- 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
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171652
- Sponsor's protocol ID
- VOSG-PE-314
- Status last verified
- Oct 2006
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Publications
Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.
PubMed 20064249
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT00171652
- Acronym / sponsor ID
- VOSG-PE-314
- Conditions
- Osteoarthritis
- Keywords
- Hand osteoarthritis, Topical NSAID, Diclofenac sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Oct 2005
- First posted
- 15 Sep 2005 (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.
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of the hand
Key exclusion criteria (3 listed)
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
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 |
|---|---|---|
| Diclofenac sodium gel 1% | Drug | – |
Primary outcome
OA pain intensity in target hand at Week 4 and 6
Total AUSCAN score in target hand at Week 4 and 6
Global rating of disease activity by patient at Week 4 and 6
5 secondary outcomes
OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8
OA pain intensity in target hand and use of rescue medication recorded in diary
Global evaluation of treatment at final visit
Treatment responder rate according to OARSI criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
- Derived from this study: PubMed 20064249Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac sodium gel 1% in people with Osteoarthritis, run by Novartis at 48 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Germany, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OA pain intensity in target hand at Week 4 and 6. The study lists 3 primary outcomes in all. 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 NCT00171652, 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 11 Oct 2006; AzTrials last refreshed its copy on 8 Nov 2026.