Osteoarthritis of the KneePhase 3NCT00426621
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
A Phase 3 study testing Diclofenac Sodium Gel in people with Osteoarthritis of the Knee, run by Novartis at 64 sites in United States.
Trial summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Diclofenac Sodium Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 64 sitesUnited States
- Study dates
- Nov 2006to Jun 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee
Who cannot join
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Radiant Research - Anderson
Anderson, South Carolina, 29621
Heartland Research Associates LLC
Arkansas City, Arkansas, 67005
Walter F. Chase, M.D., P.A.
Austin, Texas, 78705
Peter A. Holt, MD
Baltimore, Maryland, 21239
Neshaminy Medical, PC
Bensalem, Pennsylvania, 19020
Lovelace Scientific Research, Inc.
Beverly Hills, California, 92011
South Jersey Medical Associates, PA
Blackwood, New Jersey, 08012
Intermountain Orthopaedics
Boise, Idaho, 83702
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Professional Clinical Research, Inc
Cadillac, Michigan, 49601
MED Investigations
Carmichael, California, 95608
East Valley Family Physicians
Chandler, Arizona, 85224
Rapid Medical Research, Inc
Cleveland, Ohio, 44122
Radiant Research
Columbus, Ohio, 43212
Radiant Research Dallas North
Dallas, Texas, 75231
Seidman Clinical Trials
Delray Beach, Florida, 33484
Westminster Family Medicine
Erie, Pennsylvania, 16506
MED Investigations, Inc.
Fair Oaks, California, 95628
Phase III Clinical Research
Fall River, Massachusetts, 02720
Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053
Universal BioPharma Research, Inc.
Fresno, California, 93703
Florida Medical Research Institute
Gainesville, Florida, 32607
Internal Medical Associates
Grand Island, Nebraska, 68803
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, 19083
South Florida Clinical Research Center
Hollywood, Florida, 33023
Health Awareness, Inc.
Jupiter, Florida, 33458
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Holston Medical Group
Kingsport, Tennessee, 37660
Suncoast Internal Medicine Consultants
Largo, Florida, 33774
AppleMed Research, Inc.
Miami, Florida, 33155
Advanced Healthcare
Milwaukee, Wisconsin, 53209
Coastal Clinical Research Inc
Mobile, Alabama, 33608
Radiant Research, Inc. - Akron
Mogadore, Ohio, 44260
Medical Specialists Clinical Research Center
Munster, Indiana, 46321
Best Clinical Trial, LLC
New Orleans, Louisiana, 70115
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Heartland Research Associates, LLC
Newton, Kansas, 67114
Sunshine Research Center, LLC
Opa-locka, Florida, 33056
Peninsula Research, Inc.
Ormond Beach, Florida, 32174
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Andres Patron DO PA
Pembroke Pines, Florida, 33028
Clinical Research Source, Inc
Perrysburg, Ohio, 43551
Radiant Research
Philadelphia, Pennsylvania, 19115
HOPE Research Institute
Phoenix, Arizona, 85050
Radiant Research - St Petersburg
Pinellas Park, Florida, 33781
Sunrise Medical Research
Plantation, Florida, 33324
Coastal Medical Research
Port Orange, Florida, 32127
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609
Quality Research, Inc.
San Antonio, Texas, 78209
Radiant Research - San Antonio
San Antonio, Texas, 78229
Santa Barbara Clinical Research, Inc
Santa Barbara, California, 93108
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
The Physicians Clinic of Spokane
Spokane, Washington, 99204
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Clinical Research Consultants, LLC
Stratford, Connecticut, 06615
Radiant Research
Stuart, Florida, 34996
Texas Research Center, LLP
Sugar Land, Texas, 77479
River Region Research, LLC
Tallassee, Alabama, 36078
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451
Omega Medical Research
Warwick, Rhode Island, 02886
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Heartland Research Associates, LLC
Wichita, Kansas, 67205
About this study
Official title: A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Diclofenac Sodium Gel, Placebo
- Keywords
- Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Sodium GelDrug
4 grams per knee, 4 times per day, for 12 weeks
PlaceboDrug
4 grams per knee, 4 times per day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Diclofenac Sodium Gel |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).
Secondary outcomes (6)
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startNov 2006
- Study completionJun 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 Osteoarthritis of the KneeStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roy Altman, MD, Principal investigator, University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426621
- Sponsor's protocol ID
- VOSG-PN-316
- Status last verified
- Dec 2007
- First submitted
- 24 Jan 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
PubMed 21174485
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00426621
- Acronym / sponsor ID
- VOSG-PN-316
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Jan 2007 (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 knee osteoarthritis.
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: Diclofenac Sodium Gel |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of the knee
Key exclusion criteria (4 listed)
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
- Other protocol defined inclusion/exclusion criteria may apply.
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 Gel4 grams per knee, 4 times per day, for 12 weeks | Drug | 1 |
| Placebo4 grams per knee, 4 times per day, for 12 weeks | Drug | 2 |
Primary outcome
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).
6 secondary outcomes
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.
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 18 Dec 2007.
- Derived from this study: PubMed 21174485Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
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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.
Roy Altman, MD principal investigator
University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac Sodium Gel in people with Osteoarthritis of the Knee, run by Novartis at 64 sites in United States.
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 4 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 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States. 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 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?
pain in the target knee (WOMAC pain index);. 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 NCT00426621, 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 18 Dec 2007.