OsteoarthritisPhase 2NCT00479427
A Study Of The Effects Of CB2 Compound Of GW842166 In Patients With Osteoarthritis
A Phase 2 study testing GW842166 in people with Osteoarthritis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and WOMAC questionnaires will be used in the study after the repeated dose to evaluate the efficacy of CB2 compound of GW842166. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- GW842166
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2007to 9 Oct 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, 50 to 80 years of age.
- A female is eligible to participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (more than 1 year since last menstrual cycle), had a tubal ligation or is surgical sterilised); or, b) child-bearing potential, has a negative pregnancy test (urine) at screen and baseline, and agrees to one of the following:
- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; or
- Implants of levonorgestral; or
- Injectable progestogen; or
- Oral contraception (combined or progestogen only); or
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- Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year; or
- Barrier method only if used with any of the above acceptable methods.
- A diagnosis of primary osteoarthritis of the knee at least 3 months in symptom duration prior to screen. For patients with OA in both knees, an index knee will be specified.
- Meets American College of Rheumatology (ACR) criteria for symptomatic osteoarthritis of the knee as defined by knee pain and radiographic evidence of osteophytes (Altman 1986)
- Global functional status I, II or III according to ACR classification (see Appendix 5).
- Patient has a minimum of 40mm on the 100mm VAS (WOMAC pain subscale) at baseline / randomisation. In addition, baseline pain must be stable for at least 72 hours prior to randomisation based on patient's assessment.
- Patient has a maximum of 80mm on the 100mm VAS (WOMAC pain subscale) at screening.
Who cannot join
- Intolerance of paracetamol.
- Any clinical or biological abnormality found at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (e.g. current malignancy, human immunodeficiency virus (HIV) infection, significant mental illness).
- QTc ≥450msecs based on a 12-lead ECG obtained over a brief recording period. This applies to QTc intervals measured either by Bazzett's or Fridericia's formula (machine or manual over-read, male or female subjects).
- Subjects with any one of creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransfarase (AST) > 1.5 times the upper limit of normal (ULN) at screen are excluded. Subjects with two or more of bilirubin, ALT or AST above the ULN are excluded.
- Chronic Hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody
- History of chronic alcoholic liver disease
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- Impaired renal function (estimated GFR<30mL/min)
- Use of potent CYP3A4 inhibitors (e.g. amiodarone, cyclosporine, diltiazem, elfinavir, indinavir, ritonavir, cimetidine, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, miconazole, nefazodone, verapamil)
- Use of methotrexate.
- Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (excluding low-dose aspirin) or a condition associated with decreased haemostasis
- Abuse of alcohol 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). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- A history of clinically significant drug or alcohol abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria [Hochberg, 1991]
- Participation in another investigational drug or device study during the 3 months prior to the Baseline/Randomisation Visit
- Inability or unwillingness to comply with study restrictions
- An unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until three months after the last dose of study medication.
- 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 screen
- Use of lower extremity assistive devices other than a cane or knee brace (use of a 'shoe lift' is permitted)
- 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)
- Use of any analgesic, COX-2 inhibitor or NSAID [including topical NSAIDs; excluding low-dose aspirin (≤325mg per day)], other than protocol defined rescue therapy (paracetamol), within 5× half-life (in hours) prior to the first dosing day or during the study
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo Controlled Cross-over Study of the Effects of the CB2 Compound of GW842166 in Patients With Osteoarthritis
This is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and WOMAC questionnaires will be used in the study after the repeated dose to evaluate the efficacy of CB2 compound of GW842166.
- Conditions
- Osteoarthritis
- Being tested
- GW842166, Placebo
- Keywords
- osteoarthritis pain assessments
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW842166Drug
100 mg once daily
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Overall study | Experimental | overall study population Receives: Drug: GW842166; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores from Baseline to the end of treatment Western Ontario and McMasters University Osteoarthritis Index (WOMAC) using on the pain subscore for 6-8 weeks
The index consisted of 24 questions (5 for pain, 2 for stiffness and 17 for physical and composite functions). The visual analog scale (VAS; 0-100 millimeter [mm]) was utilized in this study and participants were asked to rate joint pain they had in last 24 hours in the 5 pain items. Participants were asked to rate pain while performing following activities: walking on a flat surface, going up or down stairs; at night while in bed; sitting or lying and standing upright. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Day 1 pre-dose (Baseline), Day 1 (1 hour post-dose) and Day 14 (2-4 hours post-dose). Change from Baseline was planned to be calculated by subtracting Baseline value from post-Baseline value. Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
Measured: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
Secondary outcomes (8)
Quantitative Sensory Testing (QST) rating heat pain threshold and tolerance for 6-8 weeks
Heat pain threshold was the temperature at which the participant first feels a painful stimulus. The heat pain threshold on normal skin was usually around 45 degree celcius. Mechanical pain threshold was assessed using an algometer to increase pressure against the skin of the affected joint until the point at which the participant reports pain. It was planned to assess for right knee and right forearm on Baseline (Day 1 pre-dose) and Day 14 (2-4 hours post-dose). Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from Baseline to the end of treatment in WOMAC stiffness subscore
The participants were instructed to consider his/her response not only in terms of pain and functional impairment, but also in terms of consequences to his/her personal, conjugal, professional and social activities. The VAS; 0-100 (mm) was utilized in this study and participants were asked rate how much joint pain they have in last 24 hours in the 2 pain items. Participants were asked to rate pain while performing following activities: first awakening in the morning and sitting, lying or resting later in the day. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Baseline (Day 1 pre-dose) and Day 14 (2-4 hours post-dose). Change from Baseline was planned to be calculated by subtracting Baseline value from post-Baseline value. Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from baseline to the end of treatment in WOMAC physical function subscore
The VAS; 0-100 (mm) was utilized in this study and participants were asked rate how much joint pain they have in last 24 hours in the 17 pain items. Participants were asked to rate pain while performing following activities: descending stairs; ascending stairs; rising from sitting; standing; bending to the floor; walking on a flat surface; getting in or out of a car/bus; going shopping; putting on your socks or tights; rising from bed; taking off your socks or tights; lying in bed; getting in or out of the bath; sitting; getting on or off the toilet; performing heavy domestic duties and performing light domestic duties. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Baseline (Day 1 pre-dose) and Day 14 (2-4 hours post-dose). Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
Measured: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from baseline to the end of treatment in participants' and Physician's Global assessment of arthritis condition
The VAS; 0-100 (mm) was utilized in this study and participants were asked rate how much joint pain they have in last 24. Participants were asked 'considering all the ways your osteoarthritis (study knee) affects you (him/her), how are you doing today' by investigator for participants' (Physician's) Global assessment. Higher score (100) indicates very poor and lower score (0) indicates very well. It was assessed on Baseline (Day 1 pre-dose) and Day 14 (2-4 hours post-dose). Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
Measured: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
Time for the 40 meter self-paced walk test and 11 step stair climb test
The time taken for participant to walk for 40 meters from stationary to complete the walk and climb and descend 11 (dependent on site) steps with a handrail was recorded by the investigator or designee. The pain rate was also planned to assesse in participants by using 100 mm VAS after 40 meters walking. The pain was rated as 0 for No Pain and 100 for Extreme Pain. The time was also recorded for the participant to walk the first 20 meter in addition to the time for the complete walk. Due to the early termination of this study, this end point was not assessed.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Pain intensity (100mm VAS) for the 40 meter self-paced walk test and for 11 step stair climb test
The VAS; 0-100 (mm) was utilized in this study and participants were asked to walk for 40 meters from stationary to complete the walk and climb and was recorded by the investigator or designee. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Baseline (Day 1 pre-dose) and Day 14 (2-4 hours post-dose). Due to the early termination of this study, this end point was not assessed.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Percentage of participants discontinuing due to lack of efficacy
Due to the early termination of this study, this end point was not assessed.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Average total daily use of rescue medication
Up to 3 grams of paracetamol in divided doses were allowed as rescue medication per day, but participants were advised that they must refrain from rescue medication within 24 hours prior to a clinic visit (Day 1 and 14). All rescue medication use was planned to be recorded in the diary card. Due to the early termination of this study, this end point was not assessed.
Measured: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study start6 Jul 2007
- Primary completion9 Oct 2007
- Study completion9 Oct 2007
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479427
- Sponsor's protocol ID
- CBA106191
- Status last verified
- Jul 2017
- First submitted
- 24 May 2007
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled Cross-over Study of the Effects of the CB2 Compound of GW842166 in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00479427
- Acronym / sponsor ID
- CBA106191
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis pain assessments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2007 (actual)
- Primary completion
- 9 Oct 2007 (actual)
- Study completion
- 9 Oct 2007 (actual)
- First posted
- 28 May 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 is a double-blind, two-period, placebo controlled cross-over Phase IIa study. This study is to use CB2 compound of GW842166 in patients with osteoarthritis. The pain assessments and WOMAC questionnaires will be used in the study after the repeated dose to evaluate the efficacy of CB2 compound of GW842166.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall study | Experimental | Drug: GW842166, Drug: Placebooverall study population |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients, 50 to 80 years of age.
- A female is eligible to participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (more than 1 year since last menstrual cycle), had a tubal ligation or is surgical sterilised); or, b) child-bearing potential, has a negative pregnancy test (urine) at screen and baseline, and agrees to one of the following:
- A diagnosis of primary osteoarthritis of the knee at least 3 months in symptom duration prior to screen. For patients with OA in both knees, an index knee will be specified.
- Meets American College of Rheumatology (ACR) criteria for symptomatic osteoarthritis of the knee as defined by knee pain and radiographic evidence of osteophytes (Altman 1986)
- Global functional status I, II or III according to ACR classification (see Appendix 5).
Key exclusion criteria (29 listed)
- Intolerance of paracetamol.
- Any clinical or biological abnormality found at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (e.g. current malignancy, human immunodeficiency virus (HIV) infection, significant mental illness).
- QTc ≥450msecs based on a 12-lead ECG obtained over a brief recording period. This applies to QTc intervals measured either by Bazzett's or Fridericia's formula (machine or manual over-read, male or female subjects).
- Subjects with any one of creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransfarase (AST) > 1.5 times the upper limit of normal (ULN) at screen are excluded. Subjects with two or more of bilirubin, ALT or AST above the ULN are excluded.
- Chronic Hepatitis B and C, as evidenced by positive Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody
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 |
|---|---|---|
| GW842166100 mg once daily | Drug | Overall study |
| Placeboonce daily | Drug | Overall study |
Primary outcome
Change in pain scores from Baseline to the end of treatment Western Ontario and McMasters University Osteoarthritis Index (WOMAC) using on the pain subscore for 6-8 weeks
Time frame: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
The index consisted of 24 questions (5 for pain, 2 for stiffness and 17 for physical and composite functions). The visual analog scale (VAS; 0-100 millimeter [mm]) was utilized in this study and participants were asked to rate joint pain they had in last 24 hours in the 5 pain items. Participants were asked to rate pain while performing following activities: walking on a flat surface, going up or down stairs; at night while in bed; sitting or lying and standing upright. Higher score (100) indicates extreme pain and lower score (0) indicates no pain. It was assessed on Day 1 pre-dose (Baseline), Day 1 (1 hour post-dose) and Day 14 (2-4 hours post-dose). Change from Baseline was planned to be calculated by subtracting Baseline value from post-Baseline value. Due to the early termination of this study, no formal statistical analysis was performed. Only summarized data is available.
8 secondary outcomes
Quantitative Sensory Testing (QST) rating heat pain threshold and tolerance for 6-8 weeks
Time frame: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from Baseline to the end of treatment in WOMAC stiffness subscore
Time frame: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from baseline to the end of treatment in WOMAC physical function subscore
Time frame: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
Change from baseline to the end of treatment in participants' and Physician's Global assessment of arthritis condition
Time frame: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 weeks)
Time for the 40 meter self-paced walk test and 11 step stair climb test
Time frame: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Pain intensity (100mm VAS) for the 40 meter self-paced walk test and for 11 step stair climb test
Time frame: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Percentage of participants discontinuing due to lack of efficacy
Time frame: Up to Day 14 of each treatment period (approximately up to 8 weeks)
Average total daily use of rescue medication
Time frame: Up to Day 14 of each treatment period (approximately up to 8 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 11 Jul 2017.
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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
1 site in 1 country: 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, run by GlaxoSmithKline at 1 site 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 13 inclusion and 29 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 11 Jul 2017. 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 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. 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 in pain scores from Baseline to the end of treatment Western Ontario and McMasters University Osteoarthritis Index (WOMAC) using on the pain subscore for 6-8 weeks (time frame: Baseline (Day 1 pre-dose) and up to Day 14 of each treatment period (approximately up to 8 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 11 Jul 2017.