Osteoarthritis, KneePhase 3NCT00108992
Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
A Phase 3 study testing Diclofenac, topical in people with Osteoarthritis, Knee, run by Nuvo Research Inc. at 22 sites in United States.
Trial summary
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Diclofenac, topical
- How many people
- 750 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2004to Sep 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the knee, verified radiographically
- Moderate flare of pain in the knee after washout of stable therapy
- If female, non-pregnant
- Ability to swallow moderately-sized tablets
Who cannot join
- Secondary osteoarthritis of the knee
- Major knee surgery at any time, or minor knee surgery in previous year
- Severe uncontrolled heart, liver or kidney disease
- Ulcer or bleeding from the stomach
- Corticosteroid use
- Fibromyalgia
- Skin disorder of the knee
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
OMC Clinical
Beverly Hills, California, 90211
Associated Pharmaceutical Research
Buena Park, California, 90620
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, 17011
Tampa Bay Medical Research Inc.
Clearwater, Florida, 33761
Research Across America
Dallas, Texas, 75234
Medisphere Medical Research
Evansville, Indiana, 47714
Med Investigators
Fair Oaks, California, 95628
Redrock Research Center
Las Vegas, Nevada, 89146
Coastal Clinical Research
Mobile, Alabama, 36608
Clinical Research Associates
Nashville, Tennessee, 37203
Hamptom Roads Center for Clinical Research
Norfolk, Virginia, 23502-9921
Desert Medical Advances
Palm Desert, California, 92260
Redpoint Research
Phoenix, Arizona, 85029
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241
National Clinical Research
Richmond, Virginia, 23294
Synergy Medical Education Alliance
Saginaw, Michigan, 48602
Sam Clinical Research Center
San Antonio, Texas, 78229
University Orthopedics Center
State College, Pennsylvania, 16801
Boling Clinical Trials
Upland, California, 91786
Partners in Primary Care
Voorhees Township, New Jersey, 08043
Omega Medical Research
Warwick, Rhode Island, 02886
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.
Read the detailed description
During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Diclofenac, topical
- Keywords
- topical NSAID, topical diclofenac
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac, topicalDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
physical function
patient overall health assessment
Secondary outcomes (2)
stiffness
patient global assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2005 (estimated)
- Study startFeb 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- Nuvo Research Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108992
- Sponsor's protocol ID
- PEN-03-112
- Status last verified
- Jan 2007
- First submitted
- 21 Apr 2005
- Last updated
- 5 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00108992
- Acronym / sponsor ID
- PEN-03-112
- Conditions
- Osteoarthritis, Knee
- Keywords
- topical NSAID, topical diclofenac
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- Nuvo Research Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Sep 2005
- First posted
- 22 Apr 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.
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.
Detailed description
During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary osteoarthritis of the knee, verified radiographically
- Moderate flare of pain in the knee after washout of stable therapy
- If female, non-pregnant
- Ability to swallow moderately-sized tablets
Key exclusion criteria (7 listed)
- Secondary osteoarthritis of the knee
- Major knee surgery at any time, or minor knee surgery in previous year
- Severe uncontrolled heart, liver or kidney disease
- Ulcer or bleeding from the stomach
- Corticosteroid use
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, topical | Drug | – |
Primary outcome
pain
physical function
patient overall health assessment
2 secondary outcomes
stiffness
patient global assessment
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 5 Jan 2007.
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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.
22 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, topical in people with Osteoarthritis, Knee, run by Nuvo Research Inc. at 22 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 4 inclusion and 7 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 5 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. 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. 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?
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 5 Jan 2007.