Dental PainPhase 2NCT01104844
Maxi-Analgesic Phase 2 Study to Compare the Analgesic Effects in Different Dosing Groups to Treat Teeth Extraction Pain
A Phase 2 study testing Full Dose Strength, Quarter dose strength and Half dose strength in people with Dental Pain, run by AFT Pharmaceuticals, Ltd. at 1 site in United States.
Trial summary
The aim of the study is to examine the dose response relationship in the treatment of dental pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2 tablets, 1 tablet or ½ a tablet given 4 times a day. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Full Dose Strength, Quarter dose strength and Half dose strength
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provide written informed consent before initiation of any study-related procedures.
- Males and females aged at least 16 years and not more than 40 years old on the day of consent.
- Undergoing oral surgery for the extraction of 2 impacted 3rd molar teeth, one of which must be mandibular and require bone removal.
- Experiencing moderate to severe post-operative pain, as defined by a 4 point categorical pain intensity rating scale with 0 = no pain; 1 = mild pain; 2 = moderate pain and 3 = severe pain(at rest) within 6 hours after completion of surgery.
- Baseline VAS pain intensity score of > 50mm on a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
Who cannot join
- Study contra-indications:
- Has taken any NSAID or acetaminophen within 12 hours prior to the start of surgery other than aspirin ≤ 150mg/day.
- Subjects who have received any anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium®), methohexital (Brevital®).
- Known to be pregnant or possibly pregnant.
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the subject become sexually active, she must agree to use a double-barrier method of contraception). A woman 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.
- 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.
Show all 16Show fewer
- In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
- Currently or in 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 < 50kg.Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant's best interests to participate in this study.
- NSAID and/or acetaminophen contra-indications:
- Hypersensitivity to aspirin or other NSAID.
- Hypersensitivity to acetaminophen.
- Severe known hemopoietic, renal or hepatic disease, or immunosuppressed.
- History of gastric ulceration or other GI disorders that, in the opinion of the investigator make the subject unsuitable (e.g., frequent treatment of GERD, inflammatory bowel disease, etc.).
- History of severe asthma defined as asthma requiring frequent or ongoing treatment to control symptoms. Exercise-induced asthma or mild asthma not requiring ongoing treatment may not be exclusionary at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Analgesic Effects of Different Maxigesic Doses Versus Acetaminophen, Ibuprofen and Placebo for the Teeth Extraction Pain
The aim of the study is to examine the dose response relationship in the treatment of dental pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2 tablets, 1 tablet or ½ a tablet given 4 times a day.
Read the detailed description
The combination of 500 mg acetaminophen and 150 mg 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 for dental pain.
The analgesic relief from 2 tablets of the combination was around 6 hours, and so consistent with 4 times a day dosing.
The combination tablets are scored to allow for lower doses and can be given as 2 tablets (total of 1,000/300 mg), 1 tablet (500/150 mg) or ½ tablet (250/75 mg) in multiple doses.
However different dose response combinations need to be investigated to confirm the dose response curve of the combination and to compare the relative efficacy with acetaminophen and different doses of ibuprofen (lower and higher dose).
The study hypothesis is the analgesic response to three different combination doses, the three single component doses 500mg acetaminophen and 150mg and 300mg ibuprofen, and placebo administered four times daily over 24 hours for post-operative dental pain will form a representative dose response curve.
The study design is multi-centre, prospective, placebo-controlled, randomized, double-blind, factorial parallel group.
Participants will be stratified for baseline pain at inclusion (moderate or severe pain based a 4 point pain intensity rating scale).
Recruitment will continue until there are at least 350 participants in the ITT population.
Efficacy: The primary efficacy objective is to compare the time-adjusted SPIDs (Summed Pain Intensity Differences) of the VAS pain intensity scores up to 24 hours after the first dose of study medication among the 7 treatment groups to determine the form of the dose-response relationship.
Secondary efficacy objectives are:
- To compare the maximum VAS pain scores for the 24-hour period after the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
- To compare the response rates (response rate to be defined as the percentage of participants who achieve at least 50% reduction in baseline pain within 6 hours i.e. the first dose period) among the seven treatment groups to determine the form of the dose response relationship.
- To determine and compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
- To compare time to perceptible and meaningful pain relief among the seven treatment groups using the two stopwatch method.
- To compare the time to requirement for rescue medication among the seven treatment groups.
- To compare the amount of rescue medication used (defined as the number of tablets) among the seven treatment groups over the 24-hour treatment period.
- To compare the percentage of participants requiring rescue medication among the seven treatment groups.
- To compare the categorical global pain rating among the seven treatment groups.
Safety:
To compare adverse event rates (divided into serious and non-serious adverse events). Adverse events will be assessed for the 24- hour study period and up to 30 days after the final dose of study medication among the seven treatment groups.
The standard symptoms expected in subjects who have recently undergone third molar extraction will not be recorded as AEs in this study, unless they are of greater severity and/or intensity than would be expected. The events considered to be standard for the purposes of this study are:
- Oral pain.
- Facial swelling.
- Oral bleeding.
- Bruising to face, neck, and/or jaw.
- Decreased range of motion of the jaw.
- Dry socket.
The Investigators will use their clinical judgement in determining whether these symptoms are of greater severity and/or intensity than would be expected.
Planned hospital admissions and/or surgical operations for an illness or disease which existed before the drug was given or the participant was randomized in a clinical study will not be considered adverse events The incidence of known specific NSAID and acetaminophen side effects (e.g. GI ulceration, Indigestion/stomach pain, post-operative bleeding, thromboembolic events and evidence of clinical hepatitis) during the 24-hour study period and up to 30 days after the last dose will be compared among the seven treatments.
- Conditions
- Dental Pain
- Being tested
- Full Dose Strength, Quarter dose strength, Half dose strength, Acetaminophen standard dose, Ibuprofen low dose
- Keywords
- dental pain, Analgesia
- Medical subject headings
- Toothache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Dose StrengthDrug
Also called Brand name Maxigesic
Acetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets)
Quarter dose strengthDrug
Also called Maxigesic Quarter Dose
Investigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug.
Half dose strengthDrug
Also called Maxigesic half dose
Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug
Acetaminophen standard doseDrug
Also called paracetamol
Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug
Ibuprofen low doseDrug
Also called Ibuprofen
Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product
Ibuprofen high doseDrug
Also called Ibuprofen
Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug
PlaceboDrug
2 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Half dose strength | Active comparator | Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg), i.e 2 tablets equating to ½ the dose in the standard investigational drug Receives: Drug: Half dose strength |
| Quarter dose strength | Active comparator | Investigational drug quarter dose strength (acetaminophen125mg + Ibuprofen 37.5mg) i.e. 2 tablets equating to ¼ the dose in the standard investigational drug. Receives: Drug: Quarter dose strength |
| Acetaminophen standard dose | Active comparator | Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug Receives: Drug: Acetaminophen standard dose |
| ibuprofen low dose | Active comparator | Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product Receives: Drug: Ibuprofen low dose |
| Ibuprofen high dose | Active comparator | Ibuprofen High dose 300mg i.e. 2 tablets equating to twice the ibuprofen dose as in the standard investigational drug Receives: Drug: Ibuprofen high dose |
| placebo | Placebo comparator | 2 Placebo tablets Receives: Drug: Placebo |
| Full Dose Strength | Experimental | Investigational drug full dose strength (acetaminophen 500mg + ibuprofen 150mg) i.e. 2 tablets Receives: Drug: Full Dose Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time-adjusted SPIDs of the VAS pain intensity scores
The primary efficacy objective is to compare the time-adjusted SPIDs of the VAS pain intensity scores up to 24 hours after the first dose of study medication among the 7 treatment groups to determine the form of the dose-response relationship.
Measured: 24 hours after the first dose
Secondary outcomes (9)
the maximum VAS pain score
To compare the maximum VAS pain scores for the 24-hour period after the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
Measured: 24 hours after the first dose
The Response Rate
To compare the response rates (response rate to be defined as the percentage of participants who achieve at least 50% reduction in baseline pain within 6 hours i.e. the first dose period) among the seven treatment groups to determine the form of the dose response relationship.
Measured: 24 hours after the first dose
The time to peak reduction in VAS pain intensity scores
To determine and compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
Measured: 24 hours after the first dose
The time to perceptible and meaningful pain relief
To compare time to perceptible and meaningful pain relief among the seven treatment groups using the two stopwatch method.
Measured: 24 hours after the first dose
The time to requirement for rescue medication
To compare the time to requirement for rescue medication among the seven treatment groups.
Measured: 24 hours after the first dose
The amount of rescue medication used
To compare the amount of rescue medication used (defined as the number of tablets) among the seven treatment groups over the 24-hour treatment period.
Measured: 24 hours after the first dose
The percentage of participants requiring rescue medication
To compare the percentage of participants requiring rescue medication among the seven treatment groups.
Measured: 24 hours after the first dose
The categorical global pain rating
To compare the categorical global pain rating among the seven treatment groups which is obtained at the end of 24 hours study period.
Measured: 24 hours after the first dose
The incidence of adverse events
Adverse events (divided into serious and non-serious adverse events) will be assessed for the study period. Adverse events will also be determined up to 30 days after the last dose.
The incidence of individual specific NSAID and acetaminophen side effects (e.g. GI ulceration, indigestion/stomach pain, post-operative bleeding and evidence of clinical hepatitis) will be determined up to 30 days after the last dose.
Measured: up to 30 days after the last 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 2010 (estimated)
Why it stopped: The study was withdrawn due to administrative reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuss, Doctor, Principal investigator, Premier Research Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104844
- Sponsor's protocol ID
- AFT-MX-3
- Status last verified
- Jul 2013
- First submitted
- 14 Apr 2010
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.
PubMed 20007794Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
PubMed 20142348
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Analgesic Effects of Different Maxigesic Doses Versus Acetaminophen, Ibuprofen and Placebo for the Teeth Extraction Pain
- ClinicalTrials.gov ID
- NCT01104844
- Acronym / sponsor ID
- AFT-MX-3
- Conditions
- Dental Pain
- Keywords
- dental pain, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to administrative reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AFT Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- First posted
- 16 Apr 2010 (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.
The aim of the study is to examine the dose response relationship in the treatment of dental pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2 tablets, 1 tablet or ½ a tablet given 4 times a day.
Detailed description
The combination of 500 mg acetaminophen and 150 mg 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 for dental pain.
The analgesic relief from 2 tablets of the combination was around 6 hours, and so consistent with 4 times a day dosing.
The combination tablets are scored to allow for lower doses and can be given as 2 tablets (total of 1,000/300 mg), 1 tablet (500/150 mg) or ½ tablet (250/75 mg) in multiple doses.
However different dose response combinations need to be investigated to confirm the dose response curve of the combination and to compare the relative efficacy with acetaminophen and different doses of ibuprofen (lower and higher dose).
The study hypothesis is the analgesic response to three different combination doses, the three single component doses 500mg acetaminophen and 150mg and 300mg ibuprofen, and placebo administered four times daily over 24 hours for post-operative dental pain will form a representative dose response curve.
The study design is multi-centre, prospective, placebo-controlled, randomized, double-blind, factorial parallel group.
Participants will be stratified for baseline pain at inclusion (moderate or severe pain based a 4 point pain intensity rating scale).
Recruitment will continue until there are at least 350 participants in the ITT population.
Efficacy: The primary efficacy objective is to compare the time-adjusted SPIDs (Summed Pain Intensity Differences) of the VAS pain intensity scores up to 24 hours after the first dose of study medication among the 7 treatment groups to determine the form of the dose-response relationship.
Secondary efficacy objectives are:
- To compare the maximum VAS pain scores for the 24-hour period after the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
- To compare the response rates (response rate to be defined as the percentage of participants who achieve at least 50% reduction in baseline pain within 6 hours i.e. the first dose period) among the seven treatment groups to determine the form of the dose response relationship.
- To determine and compare the time to peak reduction in VAS pain intensity scores following the first dose of study medication among the seven treatment groups to determine the form of the dose response relationship.
- To compare time to perceptible and meaningful pain relief among the seven treatment groups using the two stopwatch method.
- To compare the time to requirement for rescue medication among the seven treatment groups.
- To compare the amount of rescue medication used (defined as the number of tablets) among the seven treatment groups over the 24-hour treatment period.
- To compare the percentage of participants requiring rescue medication among the seven treatment groups.
- To compare the categorical global pain rating among the seven treatment groups.
Safety:
To compare adverse event rates (divided into serious and non-serious adverse events). Adverse events will be assessed for the 24- hour study period and up to 30 days after the final dose of study medication among the seven treatment groups.
The standard symptoms expected in subjects who have recently undergone third molar extraction will not be recorded as AEs in this study, unless they are of greater severity and/or intensity than would be expected. The events considered to be standard for the purposes of this study are:
- Oral pain.
- Facial swelling.
- Oral bleeding.
- Bruising to face, neck, and/or jaw.
- Decreased range of motion of the jaw.
- Dry socket.
The Investigators will use their clinical judgement in determining whether these symptoms are of greater severity and/or intensity than would be expected.
Planned hospital admissions and/or surgical operations for an illness or disease which existed before the drug was given or the participant was randomized in a clinical study will not be considered adverse events The incidence of known specific NSAID and acetaminophen side effects (e.g. GI ulceration, Indigestion/stomach pain, post-operative bleeding, thromboembolic events and evidence of clinical hepatitis) during the 24-hour study period and up to 30 days after the last dose will be compared among the seven treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Half dose strength | Active comparator | Drug: Half dose strengthInvestigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg), i.e 2 tablets equating to ½ the dose in the standard investigational drug |
| Quarter dose strength | Active comparator | Drug: Quarter dose strengthInvestigational drug quarter dose strength (acetaminophen125mg + Ibuprofen 37.5mg) i.e. 2 tablets equating to ¼ the dose in the standard investigational drug. |
| Acetaminophen standard dose | Active comparator | Drug: Acetaminophen standard doseAcetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug |
| ibuprofen low dose | Active comparator | Drug: Ibuprofen low doseIbuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product |
| Ibuprofen high dose | Active comparator | Drug: Ibuprofen high doseIbuprofen High dose 300mg i.e. 2 tablets equating to twice the ibuprofen dose as in the standard investigational drug |
| placebo | Placebo comparator | Drug: Placebo2 Placebo tablets |
| Full Dose Strength | Experimental | Drug: Full Dose StrengthInvestigational drug full dose strength (acetaminophen 500mg + ibuprofen 150mg) i.e. 2 tablets |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Provide written informed consent before initiation of any study-related procedures.
- Males and females aged at least 16 years and not more than 40 years old on the day of consent.
- Undergoing oral surgery for the extraction of 2 impacted 3rd molar teeth, one of which must be mandibular and require bone removal.
- Experiencing moderate to severe post-operative pain, as defined by a 4 point categorical pain intensity rating scale with 0 = no pain; 1 = mild pain; 2 = moderate pain and 3 = severe pain(at rest) within 6 hours after completion of surgery.
- Baseline VAS pain intensity score of > 50mm on a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
Key exclusion criteria (16 listed)
- Has taken any NSAID or acetaminophen within 12 hours prior to the start of surgery other than aspirin ≤ 150mg/day.
- Subjects who have received any anesthetics from midnight the night prior to surgery, except for lidocaine with epinephrine, nitrous oxide, diazepam (Valium®), methohexital (Brevital®).
- Known to be pregnant or possibly pregnant.
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence (should the subject become sexually active, she must agree to use a double-barrier method of contraception). A woman 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.
- 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.
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 |
|---|---|---|
| Full Dose StrengthAlso: Brand name MaxigesicAcetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets) | Drug | Full Dose Strength |
| Quarter dose strengthAlso: Maxigesic Quarter DoseInvestigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug. | Drug | Quarter dose strength |
| Half dose strengthAlso: Maxigesic half doseInvestigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug | Drug | Half dose strength |
| Acetaminophen standard doseAlso: paracetamolAcetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug | Drug | Acetaminophen standard dose |
| Ibuprofen low doseAlso: IbuprofenIbuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product | Drug | ibuprofen low dose |
| Ibuprofen high doseAlso: IbuprofenIbuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug | Drug | Ibuprofen high dose |
| Placebo2 placebo tablets | Drug | placebo |
Primary outcome
the time-adjusted SPIDs of the VAS pain intensity scores
Time frame: 24 hours after the first dose
The primary efficacy objective is to compare the time-adjusted SPIDs of the VAS pain intensity scores up to 24 hours after the first dose of study medication among the 7 treatment groups to determine the form of the dose-response relationship.
9 secondary outcomes
the maximum VAS pain score
Time frame: 24 hours after the first dose
The Response Rate
Time frame: 24 hours after the first dose
The time to peak reduction in VAS pain intensity scores
Time frame: 24 hours after the first dose
The time to perceptible and meaningful pain relief
Time frame: 24 hours after the first dose
The time to requirement for rescue medication
Time frame: 24 hours after the first dose
The amount of rescue medication used
Time frame: 24 hours after the first dose
The percentage of participants requiring rescue medication
Time frame: 24 hours after the first dose
The categorical global pain rating
Time frame: 24 hours after the first dose
The incidence of adverse events
Time frame: up to 30 days after the last dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- Background: PubMed 20007794Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338.
- Background: PubMed 20142348Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
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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.
Michael Kuss, Doctor principal investigator
Premier Research Group Ltd.
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 Full Dose Strength, Quarter dose strength and Half dose strength in people with Dental Pain, run by AFT Pharmaceuticals, Ltd. 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 12 Jul 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
the time-adjusted SPIDs of the VAS pain intensity scores (time frame: 24 hours after 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 NCT01104844, which also lists 2 linked publications.
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 12 Jul 2013; AzTrials last refreshed its copy on 29 Oct 2026.