PainPhase 2NCT00672646
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
A Phase 2 study testing AZD1386 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 AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 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?
- AZD1386 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 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.
Who cannot join
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
- Patients with a body temperature >37.5°C at Visit 2, before start of surgical procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction
The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 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
- AZD1386, Naproxen, Placebo
- Keywords
- Analgesic effect
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
95mg, oral solution, single dose
NaproxenDrug
500mg, capsule, single dose
PlaceboDrug
AZD1386 Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| AZD1386 | Experimental | Not described Receives: Drug: AZD1386 |
| Naproxen | Active comparator | Not described Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Placebo matching AZD1386 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Difference in Percent (SPID%)
Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).
Measured: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Secondary outcomes (5)
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.
Measured: Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.
Time to First Perceptible Pain Relief
First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.
Measured: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Time to First Meaningful Pain Relief
First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.
Measured: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
VAS Pain Intensity at Rescue Intake
0 = 'No pain' 100 ='Worst pain imaginable'
Measured: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
VAS Pain on Jaw Movement at Rescue Intake
0 = 'No pain' 100 ='Worst pain imaginable'
Measured: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 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
- 103 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
- NCT00672646
- Sponsor's protocol ID
- D5090C00010
- Status last verified
- May 2012
- First submitted
- 1 May 2008
- Last updated
- 8 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT00672646
- Acronym / sponsor ID
- D5090C00010
- Conditions
- Pain
- Keywords
- Analgesic effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 8 Jun 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 AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 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 |
|---|---|---|
| AZD1386 | Experimental | Drug: AZD1386 |
| Naproxen | Active comparator | Drug: Naproxen |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching AZD1386 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- Provision of signed informed consent.
Key exclusion criteria (4 listed)
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
- Patients with a body temperature >37.5°C at Visit 2, before start of surgical procedures
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 |
|---|---|---|
| AZD138695mg, oral solution, single dose | Drug | AZD1386 |
| Naproxen500mg, capsule, single dose | Drug | Naproxen |
| PlaceboAZD1386 Placebo oral solution | Drug | Placebo |
Primary outcome
Sum of Pain Intensity Difference in Percent (SPID%)
Time frame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).
5 secondary outcomes
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
Time frame: Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.
Time to First Perceptible Pain Relief
Time frame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Time to First Meaningful Pain Relief
Time frame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
VAS Pain Intensity at Rescue Intake
Time frame: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
VAS Pain on Jaw Movement at Rescue Intake
Time frame: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 AZD1386 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 2 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 8 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 8 Jun 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?
Sum of Pain Intensity Difference in Percent (SPID%) (time frame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours). 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 8 Jun 2012.