PainPhase 2NCT00444769
Dental Pain 3rd Molar Tooth Extraction GW842166
A Phase 2 study testing GW842166 in people with Pain, run by GlaxoSmithKline at 3 sites in 3 countries.
Trial summary
This phase IIa (proof of concept) study will be conducted as a multi-centre study within the European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled, parallel group design with a positive control arm to evaluate the analgesic efficacy of pre-emptive doses of GW842166 following… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- GW842166
- How many people
- 112 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2006to 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body weight = 50 kg and BMI within the range 19 - 29.9 kg/m².
- Women may be of non-child bearing potential or they may be of child-bearing potential. - Women of child-bearing potential must use an effective method of contraception.
- Females of non-child bearing potential are defined as:
- Post-menopausal females, being amenorrhoeic for at least 2 years with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
- Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring and other tests specified in this protocol. 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
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- Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anaesthesia. At least one third molar tooth must be a fully or partially impacted in the mandible requiring bone removal.
- Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment (up to 48 hrs post dose).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Subject has a history or presence of significant organ disease or mental illness.
- A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result or positive HIV result within 3 months of screening.
- The subject has a positive pre-study urine drug or urine/breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids, Benzodiazepines and Methadone.
- Subject has been exposed to analgesics (including prescription and over the counter NSAIDs or COX-2 inhibitors) within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22769
About this study
Official title: A Multi-Centre, Randomised, Single-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy of Single Pre-Emptive Doses of GW842166X, a Non-Cannabinoid CB2 Receptor Agonist, on Pain Following Third Molar Tooth Extraction.
This phase IIa (proof of concept) study will be conducted as a multi-centre study within the European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled, parallel group design with a positive control arm to evaluate the analgesic efficacy of pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166 will be administered as a single pre-operative oral dose in male and female subjects who will be randomised to take part in one of four possible treatment regimens. Pain assessments will be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48 hr period. Safety and tolerability will be evaluated by adverse event monitoring, cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology, clinical chemistry and urinalysis).
- Conditions
- Pain
- Being tested
- GW842166
- Keywords
- analgesia, post-operative pain, GW842166, non-cannabinoid agonist, third molar tooth extraction
- Medical subject headings
- Pain, Agnosia, Pain, Postoperative
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.
Weighted mean of the pain intensity over the 10 hours post-surgery as measured by the VAS (Visual Analogue Scale)
Measured: over the 10 hours post-surgery
Secondary outcomes (1)
-Weighted mean of the pain intensity over the 10 hours post-surgery,measured by the Verbal Rating Scale -VAS and VRS mean pain scores up to 10 hours post-surgery -Elapsed time from study drug administration to rescue analgesic request
Measured: over the 10 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, PhD., Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444769
- Sponsor's protocol ID
- CBA106809
- Status last verified
- May 2009
- First submitted
- 6 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 Multi-Centre, Randomised, Single-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy of Single Pre-Emptive Doses of GW842166X, a Non-Cannabinoid CB2 Receptor Agonist, on Pain Following Third Molar Tooth Extraction.
- ClinicalTrials.gov ID
- NCT00444769
- Acronym / sponsor ID
- CBA106809
- Conditions
- Pain
- Keywords
- analgesia, post-operative pain, GW842166, non-cannabinoid agonist, third molar tooth extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 8 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.
This phase IIa (proof of concept) study will be conducted as a multi-centre study within the European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled, parallel group design with a positive control arm to evaluate the analgesic efficacy of pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166 will be administered as a single pre-operative oral dose in male and female subjects who will be randomised to take part in one of four possible treatment regimens. Pain assessments will be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48 hr period. Safety and tolerability will be evaluated by adverse event monitoring, cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology, clinical chemistry and urinalysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Body weight = 50 kg and BMI within the range 19 - 29.9 kg/m².
- Women may be of non-child bearing potential or they may be of child-bearing potential. - Women of child-bearing potential must use an effective method of contraception.
- Post-menopausal females, being amenorrhoeic for at least 2 years with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
- Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring and other tests specified in this protocol. 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
Key exclusion criteria (4 listed)
- Subject has a history or presence of significant organ disease or mental illness.
- A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result or positive HIV result within 3 months of screening.
- The subject has a positive pre-study urine drug or urine/breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids, Benzodiazepines and Methadone.
- Subject has been exposed to analgesics (including prescription and over the counter NSAIDs or COX-2 inhibitors) within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery.
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
Weighted mean of the pain intensity over the 10 hours post-surgery as measured by the VAS (Visual Analogue Scale)
Time frame: over the 10 hours post-surgery
1 secondary outcome
-Weighted mean of the pain intensity over the 10 hours post-surgery,measured by the Verbal Rating Scale -VAS and VRS mean pain scores up to 10 hours post-surgery -Elapsed time from study drug administration to rescue analgesic request
Time frame: over the 10 hours post-surgery
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, PhD. study director
GlaxoSmithKline
3 sites in 3 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 Pain, run by GlaxoSmithKline at 3 sites in 3 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 9 inclusion and 4 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 3 sites in Germany, Italy, 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?
Weighted mean of the pain intensity over the 10 hours post-surgery as measured by the VAS (Visual Analogue Scale) (time frame: over the 10 hours post-surgery). 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.