PainPhase 3NCT01216163
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
A Phase 3 study testing Novel Ibuprofen and Acetaminophen in people with Pain, run by Pfizer at 1 site in United States.
Trial summary
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Pain
- What is being tested?
- Novel Ibuprofen and Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2011
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Who cannot join
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Salt Lake City, Utah, 84124
About this study
Official title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
- Conditions
- Pain
- Being tested
- Novel Ibuprofen, Acetaminophen, Placebo
- Keywords
- Pain following third molar extraction (wisdom tooth)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel IbuprofenDrug
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
AcetaminophenDrug
Single-dose of acetaminophen (1000mg)
PlaceboDrug
Single-dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Novel Ibuprofen |
| Treatment B | Active comparator | Not described Receives: Drug: Acetaminophen |
| Treatment C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Measured: 0 to 6 hours
Time to Onset of Meaningful Relief
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Measured: 0 to 6 hours
Secondary outcomes (13)
Time to Confirmed First Perceptible Relief
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Measured: 0 to 6 hours
Pain Relief Rating (PRR)
PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).
Measured: 0 to 2, 0 to 3, 0 to 6 hours
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Measured: 0 to 2, 0 to 3, 0 to 6 hours
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Measured: 0 to 2, 0 to 3 hours
Cumulative Percentage of Participants With Meaningful Relief
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Measured: 0 to 6 hours
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Participant Global Evaluation of Study Medication
Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 2011
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 PainStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216163
- Sponsor's protocol ID
- AH-09-14
- Other IDs
- B3411002
- Status last verified
- Jul 2012
- First submitted
- 5 Oct 2010
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
PubMed 25526232
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain
- ClinicalTrials.gov ID
- NCT01216163
- Acronym / sponsor ID
- AH-09-14
- Conditions
- Pain
- Keywords
- Pain following third molar extraction (wisdom tooth)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 20 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Novel Ibuprofen |
| Treatment B | Active comparator | Drug: Acetaminophen |
| Treatment C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Key exclusion criteria (5 listed)
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])
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 |
|---|---|---|
| Novel IbuprofenSingle-dose of novel ibuprofen (equal to 400 mg ibuprofen) | Drug | Treatment A |
| AcetaminophenSingle-dose of acetaminophen (1000mg) | Drug | Treatment B |
| PlaceboSingle-dose of placebo | Drug | Treatment C |
Primary outcome
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
Time frame: 0 to 6 hours
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time to Onset of Meaningful Relief
Time frame: 0 to 6 hours
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
13 secondary outcomes
Time to Confirmed First Perceptible Relief
Time frame: 0 to 6 hours
Pain Relief Rating (PRR)
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Pain Intensity Difference (PID)
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Time-weighted Sum of Pain Intensity Difference (SPID)
Time frame: 0 to 2, 0 to 3, 0 to 6 hours
Time-weighted Sum of Pain Relief Rating (TOTPAR)
Time frame: 0 to 2, 0 to 3, 0 to 6 hours
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
Time frame: 0 to 2, 0 to 3 hours
Cumulative Percentage of Participants With Meaningful Relief
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Time to Treatment Failure
Time frame: 0 to 6 hours
Cumulative Percentage of Participants With Treatment Failure
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Cumulative Percentage of Participants With Complete Relief
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
Participant Global Evaluation of Study Medication
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25526232Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Novel Ibuprofen and Acetaminophen in people with Pain, run by Pfizer 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 5 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 20 Aug 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 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 20 Aug 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?
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6) (time frame: 0 to 6 hours). The study lists 2 primary outcomes in all. 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 NCT01216163, 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 20 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.