Osteoarthritis of the KneePhase 2NCT00484120
Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain
A Phase 2 study testing 3%-Diclofenac-Nano-Emulsion Cream in people with Osteoarthritis of the Knee, run by Pharmos at 4 sites in Israel.
Trial summary
This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- 3%-Diclofenac-Nano-Emulsion Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 4 sitesIsrael
- Study dates
- Jun 2007to Dec 2008
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 50 years of age and above.
- Patients with primary osteoarthritis in at least a single knee joint, grade 2 or 3 based on the Kellgren and Lawrence classification system.
- Radiographic evidence consistent with OA carried out within the 6 months before screening.
- Pain should have been present for at least half of the days in the previous month and for at least 48h prior to the screening visit.
- Eligible subjects must have used an oral, topical or rectal NSAID within the past 6 months before screening.
- At baseline, after a 1 week withdrawal period of analgesic/anti-inflammatory medications, subjects should have a flare of pain.
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- Able to read, comprehend, and sign the consent form.
- Examined by the authorized physician and medically cleared to participate in the study.
- In general good health and have no contraindications to any of the investigational medicinal products.
Who cannot join
- Secondary osteoarthritis.
- Presence of a serious or unstable medical condition (e.g., malignancy, severe neurological impairment or uncontrolled hypertension) or poor general health interfering with compliance or assessment at the study physician's discretion.
- OA causing significant pain in any joint other than the knees.
- Any other rheumatic or non-rheumatic joint disease or any other painful condition within the past month (e.g. fibromyalgia).
- Knee surgery or other knee trauma at any time during the previous year or subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery etc.).
- Active or history of gastrointestinal ulceration or bleeding within the past 5 years.
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- Presence of a significant active psychiatric disorder including major depression or subjects receiving anti-psychotic medication.
- Existence of any dermatological condition on the knee.
- Subjects with disabling congestive heart failure (CHF), angina, pulmonary disease.
- Clinically significant abnormal blood results.
- Subjects cannot have had an arthrocentesis prior or during the study.
- Concomitant treatment with physical and/or occupational therapy.
- Prior use of any type of NSAID or other analgesic before taking the first dose of investigational medicinal product. Rescue treatment will be allowed during the study
- Change in sedative or CNS/psychotropic agent within the past month.
- Chronic treatment with anticoagulants (e.g. Warfarin).
- Subjects under treatment with corticosteroids.
- Subjects using topical analgesics including OTC products.
- Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test.
- Active alcoholism or substance abuse.
- Has taken an investigational drug or has used an investigational device within the past 30 days.
- History of hypersensitivity and/or idiosyncrasy to diclofenac or excipients employed in this study, aspirin or other NSAIDS.
- Has previously been entered into this study.
- Any condition that in the investigator's judgement precludes participation in the study.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Barzilai Medical Center
Ashkelon, Israel, 78278
Rambam Medical Center
Haifa, 9602
Rabin Medical Center
Petah Tikva, Israel, 49100
Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis
This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.
Read the detailed description
This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- 3%-Diclofenac-Nano-Emulsion Cream, Placebo cream
- Keywords
- Osteoarthritis, Diclofenac, Nano-emulsion
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3%-Diclofenac-Nano-Emulsion CreamDrug
3%-Diclofenac-Nano-Emulsion Cream
Placebo creamDrug
Placebo cream
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3% Diclofenac NE cream Receives: Drug: 3%-Diclofenac-Nano-Emulsion Cream |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic activity as measured by the WOMAC pain subscale.
Measured: 1 month
Secondary outcomes (3)
Patient's daily pain assessment in the home diary.
Measured: 1 month
Pain on walking.
Measured: 1 month
Safety and Tolerability.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmos
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eisenberg Elon, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484120
- Sponsor's protocol ID
- PH-2007-2
- Status last verified
- Aug 2011
- First submitted
- 7 Jun 2007
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00484120
- Acronym / sponsor ID
- PH-2007-2
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Diclofenac, Nano-emulsion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PharmosIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Jun 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 valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.
Detailed description
This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment.
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: 3%-Diclofenac-Nano-Emulsion Cream3% Diclofenac NE cream |
| 2 | Placebo comparator | Drug: Placebo cream |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females 50 years of age and above.
- Patients with primary osteoarthritis in at least a single knee joint, grade 2 or 3 based on the Kellgren and Lawrence classification system.
- Radiographic evidence consistent with OA carried out within the 6 months before screening.
- Pain should have been present for at least half of the days in the previous month and for at least 48h prior to the screening visit.
- Eligible subjects must have used an oral, topical or rectal NSAID within the past 6 months before screening.
Key exclusion criteria (23 listed)
- Secondary osteoarthritis.
- Presence of a serious or unstable medical condition (e.g., malignancy, severe neurological impairment or uncontrolled hypertension) or poor general health interfering with compliance or assessment at the study physician's discretion.
- OA causing significant pain in any joint other than the knees.
- Any other rheumatic or non-rheumatic joint disease or any other painful condition within the past month (e.g. fibromyalgia).
- Knee surgery or other knee trauma at any time during the previous year or subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain (e.g. arthroscopic techniques, osteotomy, joint replacement surgery etc.).
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 |
|---|---|---|
| 3%-Diclofenac-Nano-Emulsion Cream3%-Diclofenac-Nano-Emulsion Cream | Drug | 1 |
| Placebo creamPlacebo cream | Drug | 2 |
Primary outcome
Analgesic activity as measured by the WOMAC pain subscale.
Time frame: 1 month
3 secondary outcomes
Patient's daily pain assessment in the home diary.
Time frame: 1 month
Pain on walking.
Time frame: 1 month
Safety and Tolerability.
Time frame: 1 month
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 2 Aug 2011.
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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.
Eisenberg Elon, MD principal investigator
Rambam Health Care Campus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3%-Diclofenac-Nano-Emulsion Cream in people with Osteoarthritis of the Knee, run by Pharmos at 4 sites in Israel.
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 9 inclusion and 23 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Analgesic activity as measured by the WOMAC pain subscale. (time frame: 1 month). 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 2 Aug 2011.