Osteoarthritis, KneePhase 2NCT00447486
A Study of GW842166 in Adults With Osteoarthritis Pain
A Phase 2 study testing GW842166 in people with Osteoarthritis, Knee, run by GlaxoSmithKline at 22 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- GW842166
- How many people
- 308 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Apr 2007to not given
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female outpatient, >= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- meets ARA functional status requirements
- meets WOMAC pain subscale score requirements
- has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen
Who cannot join
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
- history of peptic ulceration or GI bleeding
- use of protocol-specified medications
- secondary cause of knee OA
- lower extremity surgery within 6 months of screening
- use of analgesics other than allowed per protocol
- use of corticosteroids or hyaluronan outside of allowed window prior to screening
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Germany9 sites
GSK Investigational Site
Berlin, State of Berlin, 10559
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Berlin, State of Berlin, 12051
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Munich, Bavaria, 80333
GSK Investigational Site
Schmiedeberg, Saxony, 01762
Sweden6 sites
GSK Investigational Site
Gothenburg, SE-412 55
GSK Investigational Site
Gothenburg, SE-416 85
GSK Investigational Site
Helsingborg, SE-252 78
GSK Investigational Site
Höllviken, SE-236 51
GSK Investigational Site
Stocholm, SE-17176
GSK Investigational Site
Upplands Vasby, SE-194 89
Spain5 sites
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
Centelles
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Petrer/Alicante
GSK Investigational Site
Santiago de Compostela, 15706
Denmark2 sites
GSK Investigational Site
Hvidovre, 2650
GSK Investigational Site
Odense C, 5000
About this study
Official title: A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- GW842166
- Keywords
- Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW842166Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
Measured: 4 Weeks
Secondary outcomes (1)
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startApr 2007
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, BSc MB PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447486
- Sponsor's protocol ID
- CBA109389
- Status last verified
- May 2009
- First submitted
- 12 Mar 2007
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00447486
- Acronym / sponsor ID
- CBA109389
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- First posted
- 14 Mar 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.
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female outpatient, >= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
- meets ARA functional status requirements
- meets WOMAC pain subscale score requirements
- has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen
Key exclusion criteria (8 listed)
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
- history of peptic ulceration or GI bleeding
- use of protocol-specified medications
- secondary cause of knee OA
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 |
|---|---|---|
| GW842166 | Drug | – |
Primary outcome
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
Time frame: 4 Weeks
1 secondary outcome
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
Time frame: 4 Weeks
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 May 2009.
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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, BSc MB PhD study director
GlaxoSmithKline
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW842166 in people with Osteoarthritis, Knee, run by GlaxoSmithKline at 22 sites in 4 countries.
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 5 inclusion and 8 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 May 2009. 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 Germany, Sweden, Spain, Denmark. 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 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?
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline (time frame: 4 Weeks). 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 18 May 2009.