Osteoarthritis, KneeNCT01557816
Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
A study testing Naproxen in people with Osteoarthritis, Knee, run by Analgesic Solutions at 1 site in United States.
Trial summary
This study aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2012
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject able to read, comprehend and sign written Informed Consent Form
- Subject is 21 years old or older
- If female, should be post-menopausal or has negative urine test
- Subject has some degree of target joint pain for the last 3 months
- Subject has to have 3 out of six:
- ( )Age > 50 ( )Morning stiffness < 30 minutes ( )Crepitus on active motion ( )Bony enlargement ( )No palpable warmth of synovium
Show all 10Show fewer
- Subject had an X-ray of the target knee showing evidence of OA within the past 3 years
- Target joint does not contain any type of orthopedic and/or prosthetic device
- Subject is ambulatory
- Subject is in good general medical and psychological health, and is capable of completing study assessments and procedures.
Who cannot join
- Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4
- Subject has any pain syndrome that has the potential to confound the assessment of the target knee.
- the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen
- Subject is pregnant or breast feeding
- Subject has sitting systolic pressure > 180 mmHg or < 90mmHg, and/or a sitting diastolic pressure > 100 mmHg or < 50 mmHg at screening
- Subject has mass body index (BMI) > 35 kg/m2.
Show all 27Show fewer
- Subject has a Hospital Anxiety and Depression Scale (HADS) score > 12 on either subscale or has an established history of major depressive disorder not controlled with medication
- Subject has had an introduction of physiotherapy, acupuncture, or transcutaneous electrical nerve stimulation within 4 weeks before screening, or has no stable regimen of these modalities.
- Subject has a clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis.
- Subject has a significant history or renal impairment
- Subject has a positive urine drug screen for alcohol, illicit drugs or nonprescribed controlled substances
- Subject has dermatological lesions of the target knee or ipsilateral elbow at the time of screening.
- Subject is unable to discontinue all formulations of prior analgesics
- Subject has received any investigational drug within 30 days prior to screening
- Subject has a history of active peptic ulceration, gastrointestinal bleeding, esophageal, or gastric or duodenal ulcer within 3 months of screening
- Subject has had a surgical intervention for any pain within 3 months of screening or plans for surgical intervention while in the study
- Subject has a documented history of inflammatory arthritis, including rheumatoid arthritis.
- Subject has received local corticosteroid injections, viscosupplementation, or arthrocentesis in the target joint within 3 months of screening
- Subject has received oral or intramuscular corticosteroids within the past 30 days
- Subject is involved in an ongoing or settled worker's compensation claim, disability, or litigation related to any pain problem
- Subject had used opioids for pain more than 4 days in the week preceding screening
- Subject has a history of alcohol or drug abuse/dependence/misuse within 2 years of screening
- Subject has history of acute coronary syndrome, ischemic or hemorrhagic stroke, transient ischemic attack, or previous revascularization procedure to coronary or peripheral vasculature, or has a history of congestive heart failure within 5 years of screening
- Subject has had axillary lymph nodes removed bilaterally
- Subject has a disease-related or iatrogenic coagulopathy, or had been diagnosed with thrombocytopenia or a functional platelet disorder
- The subject is currently on an aromatase inhibitor.
- Subject has a history of any condition that, in the Investigator's opinion, precludes participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Analgesic Solutions
Natick, Massachusetts, 01760
Stephen Wright, MD, 781-444-9605 ext. 101, swright@analgesicsolutions.com
Pura Requintina, Ph.D., 781-444-9605 ext. 121, prequintina@analgesicsolutions.com
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Cross-over, Exploratory Trial of Naproxen to Evaluate Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
This study aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have another week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication.
Read the detailed description
This study aims to evaluate various methods of measuring pain relief in osteoarthritis (OA) of the knee. The duration of the study will be up to 5 weeks. Eligible subjects will have chronic OA of the knee. After meeting initial entry criteria and prior to randomization, there will be a 1 week wash-out from existing therapy. Subjects will then be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have a week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, nor will they be allowed to use topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication (as needed up to 2 g/day)but subjects will be told not to take acetaminophen at least 12 hours before study visits. Seventy (70) subjects will be randomized to ensure that 60 subjects complete both treatment arms.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Naproxen, Placebo
- Keywords
- osteoarthritis, knee, Naproxen
- 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.
NaproxenDrug
Also called Aleve, Naprosyn
Naproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods.
PlaceboDrug
Also called Sugar pill
Placebo for seven days given BID during either of the 2 treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen; Drug: Placebo |
| Placebo | Sham comparator | Not described Receives: Drug: Naproxen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of naproxen vs. placebo
Efficacy of naproxen VS placebo will be analyzed by efficacy end-points of within-subject difference. Efficacy evaluations will include:
- In-clinic pain intensity NRS (24-hour recall)
- WOMAC: pain subscale, stiffness subscale, function subscale, and total scores
- Daily actiwatch pain intensity
- In-clinic pain intensity NRS for curent pain at rest and after exercise
- Thermal pain matching at rest and after exercise
- PGIC (Patient's Global Impression of Change)
- Subject treatment reference
Measured: 5 weeks
Safety
Safety of Naproxen VS Placebo
Safety evaluations will include:
- Adverse events (AEs)and serious AEs (SAEs)
- Vital signs
- Clinical Laboratories
- Concomitant medications
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Wright, MD, Principal investigator, Analgesic Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557816
- Sponsor's protocol ID
- ALPMF-006-2010
- Status last verified
- Feb 2012
- First submitted
- 21 Feb 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Cross-over, Exploratory Trial of Naproxen to Evaluate Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
- ClinicalTrials.gov ID
- NCT01557816
- Acronym / sponsor ID
- ALPMF-006-2010
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, Naproxen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 20 Mar 2012 (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 aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have another week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication.
Detailed description
This study aims to evaluate various methods of measuring pain relief in osteoarthritis (OA) of the knee. The duration of the study will be up to 5 weeks. Eligible subjects will have chronic OA of the knee. After meeting initial entry criteria and prior to randomization, there will be a 1 week wash-out from existing therapy. Subjects will then be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have a week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, nor will they be allowed to use topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication (as needed up to 2 g/day)but subjects will be told not to take acetaminophen at least 12 hours before study visits. Seventy (70) subjects will be randomized to ensure that 60 subjects complete both treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Active comparator | Drug: Naproxen, Drug: Placebo |
| Placebo | Sham comparator | Drug: Naproxen, Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject able to read, comprehend and sign written Informed Consent Form
- Subject is 21 years old or older
- If female, should be post-menopausal or has negative urine test
- Subject has some degree of target joint pain for the last 3 months
- Subject has to have 3 out of six:
Key exclusion criteria (27 listed)
- Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4
- Subject has any pain syndrome that has the potential to confound the assessment of the target knee.
- the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen
- Subject is pregnant or breast feeding
- Subject has sitting systolic pressure > 180 mmHg or < 90mmHg, and/or a sitting diastolic pressure > 100 mmHg or < 50 mmHg at screening
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 |
|---|---|---|
| NaproxenAlso: Aleve, NaprosynNaproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods. | Drug | Naproxen, Placebo |
| PlaceboAlso: Sugar pillPlacebo for seven days given BID during either of the 2 treatment periods. | Drug | Naproxen, Placebo |
Primary outcome
Efficacy of naproxen vs. placebo
Time frame: 5 weeks
Efficacy of naproxen VS placebo will be analyzed by efficacy end-points of within-subject difference. Efficacy evaluations will include: * In-clinic pain intensity NRS (24-hour recall) * WOMAC: pain subscale, stiffness subscale, function subscale, and total scores * Daily actiwatch pain intensity * In-clinic pain intensity NRS for curent pain at rest and after exercise * Thermal pain matching at rest and after exercise * PGIC (Patient's Global Impression of Change) * Subject treatment reference
Safety
Time frame: 5 weeks
Safety of Naproxen VS Placebo Safety evaluations will include: * Adverse events (AEs)and serious AEs (SAEs) * Vital signs * Clinical Laboratories * Concomitant medications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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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.
Stephen Wright, MD principal investigator
Analgesic Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen in people with Osteoarthritis, Knee, run by Analgesic Solutions at 1 site 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 10 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 22 Mar 2012. 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Wright, M.D. (781-444-9605 ext. 101, swright@analgesicsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of naproxen vs. placebo (time frame: 5 weeks). The study lists 2 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 22 Mar 2012.