PainPhase 2NCT00659490
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
A Phase 2 study testing AZD1940 and Naproxen in people with Pain, run by AstraZeneca at 1 site in United States.
Trial summary
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- AZD1940 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- Provision of signed informed consent.
- Healthy males or non-fertile females.
Who cannot join
- History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.
- Conditions
- Pain
- Being tested
- AZD1940, Naproxen, Placebo
- Keywords
- Analgesic effect, Molar extraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1940Drug
800ug oral administration
NaproxenDrug
Also called Naprosyn
500mg oral administration
PlaceboDrug
Placebo given pre-surgery
| Study group | Role | What they receive |
|---|---|---|
| AZD1940 | Experimental | AZD1940 800ug given predose Receives: Drug: AZD1940 |
| Naproxen | Active comparator | Naproxen 500mg given pre-surgery Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Placebo given pre-surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Area Under the Curve 0-8h (AUC0-8h)
Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.
Measured: 0-8 h(from end of surgery to 8 hours post surgery)
Secondary outcomes (21)
Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)
Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.
Measured: 0-4h (from end of surgery to 4 hours post surgery)
Maximum Pain Based on VAS Scale
Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.
Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)
Measured: From end of surgery to 8h or time first intake of rescue medication (whichever came first)
Mean Pain Based on a VAS Scale
Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)
Measured: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Jaw Movement AUC0-8h
Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)
Measured: 0-8h from end of surgery to 8 hours post surgery
Pain at Jaw Movement AUC0-4h
Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).
Measured: 0-4h after end of surgery to 4 hours post surgery
Maximum Pain at Jaw Movement
Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.
Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)
Measured: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Mean Pain at Jaw Movement
Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).
Measured: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Rescue Medication
Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.
Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable).
Measured: At time of first rescue medication taken before 8 hours after end of surgery
Pain at Jaw Movement at Time of First Rescue Medication
Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.
Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable).
Measured: At time of first rescue medication (before 8 hours after end on surgery)
Time to First Intake of Rescue Medication.
Measured: From end of surgery to 8 hours following surgery
Number of Patients Requesting Rescue Medication
Observed case.
Measured: End of surgery up to 8hours following surgery
Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Maximum Deterioration in VAMS High
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Anxious
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Sedated
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Down
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Stimulated
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS High
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Anxious
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Sedated
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Down
Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.
Measured: Between dosing and 12h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynn Webster, MD, Principal investigator, Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USABror Jonzon, Study chair, AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659490
- Sponsor's protocol ID
- D3120C00006
- Status last verified
- May 2010
- First submitted
- 10 Apr 2008
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT00659490
- Acronym / sponsor ID
- D3120C00006
- Conditions
- Pain
- Keywords
- Analgesic effect, Molar extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD1940 | Experimental | Drug: AZD1940AZD1940 800ug given predose |
| Naproxen | Active comparator | Drug: NaproxenNaproxen 500mg given pre-surgery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given pre-surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- Provision of signed informed consent.
- Healthy males or non-fertile females.
Key exclusion criteria (2 listed)
- History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
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 |
|---|---|---|
| AZD1940800ug oral administration | Drug | AZD1940 |
| NaproxenAlso: Naprosyn500mg oral administration | Drug | Naproxen |
| PlaceboPlacebo given pre-surgery | Drug | Placebo |
Primary outcome
Pain Area Under the Curve 0-8h (AUC0-8h)
Time frame: 0-8 h(from end of surgery to 8 hours post surgery)
Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.
21 secondary outcomes
Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)
Time frame: 0-4h (from end of surgery to 4 hours post surgery)
Maximum Pain Based on VAS Scale
Time frame: From end of surgery to 8h or time first intake of rescue medication (whichever came first)
Mean Pain Based on a VAS Scale
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Jaw Movement AUC0-8h
Time frame: 0-8h from end of surgery to 8 hours post surgery
Pain at Jaw Movement AUC0-4h
Time frame: 0-4h after end of surgery to 4 hours post surgery
Maximum Pain at Jaw Movement
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Mean Pain at Jaw Movement
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Rescue Medication
Time frame: At time of first rescue medication taken before 8 hours after end of surgery
Pain at Jaw Movement at Time of First Rescue Medication
Time frame: At time of first rescue medication (before 8 hours after end on surgery)
Time to First Intake of Rescue Medication.
Time frame: From end of surgery to 8 hours following surgery
Number of Patients Requesting Rescue Medication
Time frame: End of surgery up to 8hours following surgery
Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
Time frame: Between dosing and 12h post-dose
Maximum Deterioration in VAMS High
Time frame: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Anxious
Time frame: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Sedated
Time frame: Between dosing and 12h post-dose
Maximum Deterioration in VAMS Down
Time frame: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Stimulated
Time frame: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS High
Time frame: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Anxious
Time frame: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Sedated
Time frame: Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Down
Time frame: Between dosing and 12h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lynn Webster, MD principal investigator
Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
Bror Jonzon study chair
AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden
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 AZD1940 and Naproxen in people with Pain, run by AstraZeneca 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 3 inclusion and 2 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 Jun 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.
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?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Area Under the Curve 0-8h (AUC0-8h) (time frame: 0-8 h(from end of surgery to 8 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 11 Jun 2012.