Dental PainPhase 3NCT01420653
Maxigesic 325 Acute Dental Pain Study
A Phase 3 study testing Maxigesic 325, Acetaminophen and Ibuprofen in people with Dental Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Maxigesic 325, Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provides written informed consent before initiation of any study-related procedures.
- Males and females aged at least 10 years and not more than 60 years old on the day of consent.
- Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
- A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
Who cannot join
- Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
- Subjects who have received any anaesthetics within 24 hours prior to surgery
- Hypersensitivity to opioids
- Known to be pregnant or possibly pregnant
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
- Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
Show all 13Show fewer
- Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
- In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
- Currently, or in the last 30 days, has been in a clinical trial involving another study drug.
- Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
- Participant weight < 50 kg or > 120 kg.
- Has a history of drug or alcohol abuse.
- Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the participants best interests to participant in the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
New Zealand3 sites
Clinical Solutions Ltd.
Auckland, 0622
Southern Clinical Trials
Christchurch
Clinical Trial New Zealand
Hamilton, Waikato Region
About this study
Official title: Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.
Read the detailed description
The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve analgesia compared with the individual components, when given as 2 tablets (i.e. total of 1,000/300 mg) 4 times a day.
Recent concerns over the safety of acetaminophen have led to some regulatory agencies restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the maximum daily dose of 4000mg per day.
A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose of 3900mg acetaminophen and 1170mg ibuprofen.
The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity scores up to 48 hours after the first dose of study medication among the four study groups.
Secondary objectives are:
To compare the time to onset of pain relief after the first dose of study drug defined as (i) perceptible and (ii) meaningful pain relief among the four study groups using the two stopwatch method.
To compare the maximum VAS pain scores up to 48 hours after the first dose of study medication among the four study groups.
To compare the response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure) among the four study groups.
To compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the four study groups.
To compare the time to requirement for rescue medication among the four study groups.
To compare the percentage of participants who use rescue medication among the four study groups.
To compare the amount of rescue medication used (defined as number of tablets) among the four study groups.
To compare the categorical global pain rating among the four study groups.
Safety:
To compare adverse event rates for the 48-hour study period and up to Day 30 among the four treatment groups.
To compare the incidence of known specific NSAID and paracetamol side effects (e.g. GI ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin rashes, water retention, renal failure, thromboembolic events and evidence of clinical hepatitis) during the 48-hour study period and up to Day 30 among the four study groups.
Planned hospital admissions and/or surgical operations for an illness or disease which existed before the study drug was given or the participant was randomized in the study will not be considered adverse events.
- Conditions
- Dental Pain
- Being tested
- Maxigesic 325, Acetaminophen, Ibuprofen, Placebo
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxigesic 325Drug
Also called Maxigesic
Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
AcetaminophenDrug
Also called paracetamol
Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
IbuprofenDrug
Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
PlaceboDrug
placebo, three tablets four times a day, with food for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Maxigesic 325 | Experimental | Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally Receives: Drug: Maxigesic 325 |
| Acetaminophen | Active comparator | Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally Receives: Drug: Acetaminophen |
| Ibuprofen | Active comparator | Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Placebo tablets, every 6 hours, orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID (Summed Pain Intensity Differences)
The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication.
This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
Measured: 48 hours afte the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionJan 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Currie, Doctor, Principal investigator, Clinical Trial New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420653
- Sponsor's protocol ID
- AFT-MX-6
- Status last verified
- Jan 2015
- First submitted
- 16 Aug 2011
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Daniels SE, Atkinson HC, Stanescu I, Frampton C. Analgesic Efficacy of an Acetaminophen/Ibuprofen Fixed-dose Combination in Moderate to Severe Postoperative Dental Pain: A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial. Clin Ther. 2018 Oct;40(10):1765-1776.e5. doi: 10.1016/j.clinthera.2018.08.019. Epub 2018 Sep 21.
PubMed 30245281
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain
- ClinicalTrials.gov ID
- NCT01420653
- Acronym / sponsor ID
- AFT-MX-6
- Conditions
- Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- AFT Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 6 Dec 2018
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 the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.
Detailed description
The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve analgesia compared with the individual components, when given as 2 tablets (i.e. total of 1,000/300 mg) 4 times a day.
Recent concerns over the safety of acetaminophen have led to some regulatory agencies restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the maximum daily dose of 4000mg per day.
A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose of 3900mg acetaminophen and 1170mg ibuprofen.
The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity scores up to 48 hours after the first dose of study medication among the four study groups.
Secondary objectives are:
To compare the time to onset of pain relief after the first dose of study drug defined as (i) perceptible and (ii) meaningful pain relief among the four study groups using the two stopwatch method.
To compare the maximum VAS pain scores up to 48 hours after the first dose of study medication among the four study groups.
To compare the response rates (response rate to be defined as the percentage of participants who reduce their pain intensity scores by at least 50% compared with the baseline VAS measure) among the four study groups.
To compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the four study groups.
To compare the time to requirement for rescue medication among the four study groups.
To compare the percentage of participants who use rescue medication among the four study groups.
To compare the amount of rescue medication used (defined as number of tablets) among the four study groups.
To compare the categorical global pain rating among the four study groups.
Safety:
To compare adverse event rates for the 48-hour study period and up to Day 30 among the four treatment groups.
To compare the incidence of known specific NSAID and paracetamol side effects (e.g. GI ulceration or bleeding, indigestion/stomach pain, post-operative bleeding, bronchospasm, skin rashes, water retention, renal failure, thromboembolic events and evidence of clinical hepatitis) during the 48-hour study period and up to Day 30 among the four study groups.
Planned hospital admissions and/or surgical operations for an illness or disease which existed before the study drug was given or the participant was randomized in the study will not be considered adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maxigesic 325 | Experimental | Drug: Maxigesic 325Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally |
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets, every 6 hours, orally |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provides written informed consent before initiation of any study-related procedures.
- Males and females aged at least 10 years and not more than 60 years old on the day of consent.
- Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
- A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
Key exclusion criteria (13 listed)
- Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
- Subjects who have received any anaesthetics within 24 hours prior to surgery
- Hypersensitivity to opioids
- Known to be pregnant or possibly pregnant
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
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 |
|---|---|---|
| Maxigesic 325Also: MaxigesicMaxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours | Drug | Maxigesic 325 |
| AcetaminophenAlso: paracetamolAcetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours | Drug | Acetaminophen |
| IbuprofenIbuprofen 97.5mg, three tablets four times a day, with food for 48 hours. | Drug | Ibuprofen |
| Placeboplacebo, three tablets four times a day, with food for 48 hours | Drug | Placebo |
Primary outcome
SPID (Summed Pain Intensity Differences)
Time frame: 48 hours afte the first dose
The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication. This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30245281Daniels SE, Atkinson HC, Stanescu I, Frampton C. Analgesic Efficacy of an Acetaminophen/Ibuprofen Fixed-dose Combination in Moderate to Severe Postoperative Dental Pain: A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial. Clin Ther. 2018 Oct;40(10):1765-1776.e5. doi: 10.1016/j.clinthera.2018.08.019. Epub 2018 Sep 21.
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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.
John Currie, Doctor principal investigator
Clinical Trial New Zealand
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maxigesic 325, Acetaminophen and Ibuprofen in people with Dental Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in 2 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 4 inclusion and 13 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in New Zealand, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Dec 2018). 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?
SPID (Summed Pain Intensity Differences) (time frame: 48 hours afte the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420653, which also lists 1 linked publication.
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 6 Dec 2018.