OsteoarthritisPhase 2NCT01231490
Acute Osteoarthritis Experimental Model Study.
A Phase 2 study testing Naproxen in people with Osteoarthritis, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
This is a methodological study designed to investigate a new model for testing pain agents in the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised, placebo controlled three-way cross-over study in patients with OA of the knee. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2008to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of OA of the knee and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 50 to 75 years of age inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential defined as:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
- Females with menopausal status ( > 12 months of spontaneous amenorrhea) and receiving hormone replacement therapy (HRT) treatment for more than 3 months.
- BMI within the range 15-35 kg/m2 (inclusive).
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- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- Diagnosis
- Have a radiological and clinical diagnosis of OA based upon Arthritis Research Council (ACR) (Appendix 3) criteria affecting at least one knee of a minimum of 3 months in symptom duration prior to screening. An X-ray will be performed at screening if required.
- Have symptomatic OA of at least one knee. The symptoms should be significantly worse in one knee than the other if OA affects both knees.
- When questioned, confirm they experience moderate pain when climbing stairs.
- Be able to walk unaided or with the aid of one stick (2 sticks not allowed)
- A minimum of 4 out 10 on the NRS (numerical rating scales) at screening and/ or a requirement for the use of an analgesic for the pain in the OA knee for most days during the previous three months. In addition, baseline pain must be stable for at least 72 hours prior to day 1 based on patient's assessment or day 1 may be delayed.
- A maximum of 8 out of 10 on the NRS at screening. Enrollement may be delayed if, in the opinion of the investigator, the severity of pain represents an isolated incident.
- In good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination and suitable for treatment with both naproxen and paracetamol.
Who cannot join
- General
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. However, a positive drug screen will not automatically exclude a subject if there is a valid explanation for the positive result other than drug abuse e.g. poppy seeds.
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- Intolerance of paracetamol or not response to Non Steriodal Anti Inflammatory Drugs (NSAID) therapy.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (excluding low-dose aspirin) or a condition associated with decreased haemostasis.
- Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Please also see OA exclusion criteria 10.
- Subject with a known allergy to or judged by the investigator not to be a suitable candidate for naproxen or paracetamol therapy based on medical history, concomitant medications, and concurrent systemic disease as described in the product labelling
- History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. In particular dyspepsia, peptic ulceration, gastrointestinal bleeding, ulcerative colitis or Crohn´s disease
- Presence of anaemia.
- Subjects who have asthma, have received anti-asthmatic medication within the last 5 years, have a history of NSAID-sensitive asthma or who have ever required hospital admission due to asthma.
- Presence of cardiac heart failure NYHA > 1.
- Presence of hypertension (BP systolic > 150 mmHg, diastolic > 90 mmHg) not adequately controlled by antihypertensive treatment.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Unwillingness or inability to follow the procedures outlined in the protocol including being able to undertake the walking as defined in the protocol.
- Inability or unwillingness to comply with study restrictions.
- Secondary causes of arthritis of the knee including septic arthritis, inflammatory joint disease, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, and primary osteochondromatosis.
- Had lower extremity surgery (including arthroscopy) within 6 months prior to screening or scheduled for surgery of any kind during the study period
- Significant prior injury to the index knee within 12 months prior to screening.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
- Any other musculoskeletal or arthritic condition that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (i.e., currently symptomatic fractures or any concurrent rheumatic disease such as but not limited to fibromyalgia, rheumatoid arthritis, and Reiter's syndrome are excluded).
- Corticosteroid use prior to baseline as follows:
- Intra-articular injection of steroids to the index knee within the previous 3 months
- Intra-articular steroid injections into any site other than the index knee within the previous 1 month
- Intra-muscular corticosteroid injections within the previous 3 months
- Oral corticosteroids within the previous 1 month
- Received hyaluronan injections into index knee within the previous six months prior to baseline.
- Initiation of or change to an established physiotherapy program within 2 weeks prior to baseline or during the study period. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity.
- Recent start or change in dose regimen ( 3 months prior to baseline) of any OA specific therapies (i.e., nutraceutical products) including but not limited to chondroitin or keratin sulfate, s-adenosyl methionine (SAMe) and glucosamine preparations.
- Use of opioid analgesics other than codeine containing preparations.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA
GSK Investigational Site
Cardiff, CF14 5GJ
GSK Investigational Site
Manchester, M15 6SX
About this study
Official title: A Double Blind, Randomised, Placebo Controlled Methodological Cross-over Study to Investigate the Senstivity of a Novel Study Design and Endpoints to Treatment Effects of Naproxen in Osteoarthritis
This is a methodological study designed to investigate a new model for testing pain agents in the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised, placebo controlled three-way cross-over study in patients with OA of the knee.
Read the detailed description
The study will include an interim analysis after approximately 50 patients have been randomised. Up to 100 patients with painful Osteoarthritis (OA) of the knee may be recruited into the study. Eligible subjects will wash out of all treatments for their OA pain for a minimum of 7 days apart from protocol rescue medication (paracetamol). Following this, subjects will participate in three short term treatment periods with repeated administration of Naproxen (500 mg/twice daily) or placebo for 3 days. Between treatment periods subjects will receive placebo. Endpoints will include objective assessments of function (time to walk and stair climbing) and subjective assessments of pain including current pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Patient Global Impression of Change. Throughout the study subjects will be asked to rate their pain periodically. Subjects will attend the unit on Day 1 to be dispensed with study medication and to take their first dose in the unit. They will then return to the unit on Days 8, 10, 15, 17, 22 and 24 for pain assessments, with medication dispensed at each of these visits, excluding Day 24.
- Conditions
- Osteoarthritis
- Being tested
- Placebo, Naproxen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
NaproxenDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the time to ascend and descend 11 stairs
Measured: Screening, Day 1, Days 8,10,15,17,22,24
Secondary outcomes (6)
Pain intensity difference as measured on numerical rating scales (NRS) after ascending and descending 11 stairs.
Measured: Screening, Day 1,Days 8,10,15,17,22,24
Change from baseline in the time to walk 20, 40 and 100m.
Measured: Screening, Day 1, Days 8,10,15,17,22,24
Pain intensity difference as measured on a numerical rating scales (NRS) after: 100m walk
Measured: Screening, Day 1, Days 8,10,15,17,22,24
Pain intensity difference as measured on a numerical rating scales (NRS) after: resting
Measured: Screening,Day 1, Days 2 to 7, 9, 11 to 14, 16, 18 to 21, 23, Days 8,10,15,17,22,24
Change from baseline in WOMAC scores
Measured: Day 1, Days 8,10,15,17,22,24
Patient Global Impression of Change (PGIC).
Measured: Days 8,10,15,17,22,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231490
- Sponsor's protocol ID
- 111293
- Status last verified
- Jan 2011
- First submitted
- 28 Oct 2010
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised, Placebo Controlled Methodological Cross-over Study to Investigate the Senstivity of a Novel Study Design and Endpoints to Treatment Effects of Naproxen in Osteoarthritis
- ClinicalTrials.gov ID
- NCT01231490
- Acronym / sponsor ID
- 111293
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Nov 2010 (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 is a methodological study designed to investigate a new model for testing pain agents in the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised, placebo controlled three-way cross-over study in patients with OA of the knee.
Detailed description
The study will include an interim analysis after approximately 50 patients have been randomised. Up to 100 patients with painful Osteoarthritis (OA) of the knee may be recruited into the study. Eligible subjects will wash out of all treatments for their OA pain for a minimum of 7 days apart from protocol rescue medication (paracetamol). Following this, subjects will participate in three short term treatment periods with repeated administration of Naproxen (500 mg/twice daily) or placebo for 3 days. Between treatment periods subjects will receive placebo. Endpoints will include objective assessments of function (time to walk and stair climbing) and subjective assessments of pain including current pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Patient Global Impression of Change. Throughout the study subjects will be asked to rate their pain periodically. Subjects will attend the unit on Day 1 to be dispensed with study medication and to take their first dose in the unit. They will then return to the unit on Days 8, 10, 15, 17, 22 and 24 for pain assessments, with medication dispensed at each of these visits, excluding Day 24.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Naproxen |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- A diagnosis of OA of the knee and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 50 to 75 years of age inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential defined as:
- BMI within the range 15-35 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (32 listed)
- General
- Secondary causes of arthritis of the knee including septic arthritis, inflammatory joint disease, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, and primary osteochondromatosis.
- Had lower extremity surgery (including arthroscopy) within 6 months prior to screening or scheduled for surgery of any kind during the study period
- Significant prior injury to the index knee within 12 months prior to screening.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee.
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| NaproxenCapsule | Drug | Active |
Primary outcome
Change from baseline in the time to ascend and descend 11 stairs
Time frame: Screening, Day 1, Days 8,10,15,17,22,24
6 secondary outcomes
Pain intensity difference as measured on numerical rating scales (NRS) after ascending and descending 11 stairs.
Time frame: Screening, Day 1,Days 8,10,15,17,22,24
Change from baseline in the time to walk 20, 40 and 100m.
Time frame: Screening, Day 1, Days 8,10,15,17,22,24
Pain intensity difference as measured on a numerical rating scales (NRS) after: 100m walk
Time frame: Screening, Day 1, Days 8,10,15,17,22,24
Pain intensity difference as measured on a numerical rating scales (NRS) after: resting
Time frame: Screening,Day 1, Days 2 to 7, 9, 11 to 14, 16, 18 to 21, 23, Days 8,10,15,17,22,24
Change from baseline in WOMAC scores
Time frame: Day 1, Days 8,10,15,17,22,24
Patient Global Impression of Change (PGIC).
Time frame: Days 8,10,15,17,22,24
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 31 Jan 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.
GSK Clinical Trials study director
GlaxoSmithKline
3 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 Naproxen in people with Osteoarthritis, run by GlaxoSmithKline at 3 sites in United Kingdom.
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 16 inclusion and 32 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 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Change from baseline in the time to ascend and descend 11 stairs (time frame: Screening, Day 1, Days 8,10,15,17,22,24). 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 31 Jan 2011; AzTrials last refreshed its copy on 29 Oct 2026.