PainPhase 2NCT00913627
Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
A Phase 2 study testing ibuprofen and naproxen in people with Pain, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Pain
- What is being tested?
- ibuprofen and naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2009to 5 Aug 2009
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females 16 to 40 years of age.
- Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction;
- Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam;
- Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
- Examined by the attending dentist or physician and medically cleared to participate in the study;
- In general good health and have no contraindications to the study medication.
Who cannot join
- Pregnancy, as verified by a urine-based pregnancy test, or breast feeding;
- Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, poorly-controlled hyper- or hypothyroidism);
- Use of a prescription or nonprescription drug with which the administration of ibuprofen or any other NSAID is contraindicated;
- Use of a bisphosphonate (e.g., risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years;
- Acute localized dentalveolar infection at the time of surgery that could confound the post-surgical evaluation;
- Females who are of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
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- Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
- History of alcoholism (i.e., on average, consumes 3 or more alcoholic drinks per day) or substance abuse within the last year, or is currently abusing alcohol or other mood-altering drugs (e.g., cannabis). Patients who are taking CNS or other psychotropic drugs (including St. John's Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;
- Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week)
- History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to ibuprofen, naproxen, aspirin, or to any other NSAID; or to codeine, hydrocodone, or acetaminophen, or to their combinations;
- Prior use of any type of analgesic or NSAID five half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure;
- Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less before taking the first dose of study medication;
- The subject has taken an investigational product or participated in an investigational trial within 30 days of study enrollment;
- The subject has previously participated in this study;
- The subject is a member of the study site staff directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Brown Research Center
Salt Lake City, Utah, 84124
About this study
Official title: Ibuprofen 600 Mg Extended Release (er) Single-dose Dental Pain Study
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, [roller compaction] and [wet granulation] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 x 600 mg ibuprofen IR/ER-roller compaction caplet Receives: Drug: ibuprofen |
| 2 | Experimental | 1 x 600 mg ibuprofen IR/ER-Wet granulation caplet Receives: Drug: ibuprofen |
| 3 | Active comparator | 1x 220 mg naproxen sodium (Aleve caplet) Receives: Drug: naproxen |
| 4 | Placebo comparator | 1 x placebo caplet 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 Intensity Difference Score From 0 to 12 Hours (SPID 0-12)
Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).
Measured: Baseline (0 hour) to 12 hours post dose
Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)
PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).
Measured: 8 to 12 hours post dose
Secondary outcomes (15)
Time to First Perceptible Pain Relief
Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled "first perceptible relief", if the participant also depressed the second stopwatch labelled as "meaningful relief" by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently.
Measured: Baseline to 6 hours
Time to Treatment Failure
Time to first rescue medication or discontinuation due to lack of efficacy
Measured: Baseline to 24 hours
Percentage of Participants With Treatment Failure
Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.
Measured: 8, 9, 10, 11, and 12 hours
Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)
Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).
Measured: 0 to 4 hours and 4 to 8 hours
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)
Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement.
Measured: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR)
TOTPAR based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best).
Measured: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief
The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now.
Measured: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Time to Meaningful Pain Relief
Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant.
Measured: Baseline to 6 hours
Percentage of Participants Achieving Meaningful Pain Relief
Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant.
Measured: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Participant Global Evaluation of Study Medication at 12 Hours
Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).
Measured: 12 hours
Participant Global Evaluation of Study Medication at 24 Hours
Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).
Measured: 24 hours
Pain Intensity Difference (PID) Score
PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). PID score derived by subtracting postdose score from baseline score and could range from -1 to 3. A baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated greater improvement (decrease in pain intensity).
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Pain Relief (PR) Score
PR score based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None [0], A Little [1], Some [2], A Lot [3] or Complete [4]. Higher scores indicated improvement (better pain relief).
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Score
PRID=PID+PR, where PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline and could range from -1 to 3. Baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated improvement. PR: 5-point categorical pain relief scale (None [0], A Little [1], Some [2], A Lot [3], Complete [4]). PRID score could range from -1 to 7 where higher scores indicated better pain relief and decrease in pain intensity.
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Peak Pain Relief Score
Maximum PR score over the scheduled pain relief assessments. PR score based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief).
Measured: Baseline to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study start7 May 2009
- Primary completion1 Aug 2009
- Study completion5 Aug 2009
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 196 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
- NCT00913627
- Sponsor's protocol ID
- AK-09-07
- Other IDs
- B4371001
- Status last verified
- Feb 2018
- First submitted
- 29 May 2009
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen 600 Mg Extended Release (er) Single-dose Dental Pain Study
- ClinicalTrials.gov ID
- NCT00913627
- Acronym / sponsor ID
- AK-09-07
- Conditions
- Pain
- Keywords
- Extended-release, ibuprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 May 2009 (actual)
- Primary completion
- 1 Aug 2009 (actual)
- Study completion
- 5 Aug 2009 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 22 Mar 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 assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, [roller compaction] and [wet granulation] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ibuprofen1 x 600 mg ibuprofen IR/ER-roller compaction caplet |
| 2 | Experimental | Drug: ibuprofen1 x 600 mg ibuprofen IR/ER-Wet granulation caplet |
| 3 | Active comparator | Drug: naproxen1x 220 mg naproxen sodium (Aleve caplet) |
| 4 | Placebo comparator | Drug: Placebo1 x placebo caplet |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females 16 to 40 years of age.
- Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction;
- Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam;
- Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
- Examined by the attending dentist or physician and medically cleared to participate in the study;
Key exclusion criteria (15 listed)
- Pregnancy, as verified by a urine-based pregnancy test, or breast feeding;
- Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, poorly-controlled hyper- or hypothyroidism);
- Use of a prescription or nonprescription drug with which the administration of ibuprofen or any other NSAID is contraindicated;
- Use of a bisphosphonate (e.g., risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years;
- Acute localized dentalveolar infection at the time of surgery that could confound the post-surgical evaluation;
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 |
|---|---|---|
| ibuprofen | Drug | 1 |
| ibuprofen | Drug | 2 |
| naproxen | Drug | 3 |
| Placebo | Drug | 4 |
Primary outcome
Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)
Time frame: Baseline (0 hour) to 12 hours post dose
Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).
Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)
Time frame: 8 to 12 hours post dose
PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).
15 secondary outcomes
Time to First Perceptible Pain Relief
Time frame: Baseline to 6 hours
Time to Treatment Failure
Time frame: Baseline to 24 hours
Percentage of Participants With Treatment Failure
Time frame: 8, 9, 10, 11, and 12 hours
Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)
Time frame: 0 to 4 hours and 4 to 8 hours
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)
Time frame: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR)
Time frame: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours
Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief
Time frame: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Time to Meaningful Pain Relief
Time frame: Baseline to 6 hours
Percentage of Participants Achieving Meaningful Pain Relief
Time frame: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes
Participant Global Evaluation of Study Medication at 12 Hours
Time frame: 12 hours
Participant Global Evaluation of Study Medication at 24 Hours
Time frame: 24 hours
Pain Intensity Difference (PID) Score
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Pain Relief (PR) Score
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Score
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours
Peak Pain Relief Score
Time frame: Baseline to 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 2 study testing ibuprofen and naproxen 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 6 inclusion and 15 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 22 Mar 2018. 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 22 Mar 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?
Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) (time frame: Baseline (0 hour) to 12 hours post dose). 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?
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 22 Mar 2018.