PainPhase 4NCT00740857
Study Comparing the Efficacy of Two Ibuprofen Formulations
A Phase 4 study testing ibuprofen Formulation 1 and ibuprofen Formulation 2 in people with Pain, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- ibuprofen Formulation 1 and ibuprofen Formulation 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 2008
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Outpatients with post-operative pain following surgical extraction of third molars,
- 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 or rescue medication.
- Exclusions criteria:
- any serious medical condition,
- acute localized dental infection at the time of surgery ,
- females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Comparing the Efficacy of Two Ibuprofen Formulations
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
- Conditions
- Pain
- Being tested
- placebo, ibuprofen Formulation 1, ibuprofen Formulation 2
- Keywords
- Dental pain analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
2 placebo gels capsules delivered as a single dose.
ibuprofen Formulation 1Drug
2 marketed ibuprofen gels
ibuprofen Formulation 2Drug
2 marketed ibuprofen gels
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Active comparator | Not described Receives: Drug: ibuprofen Formulation 1 |
| 3 | Active comparator | Not described Receives: Drug: ibuprofen Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Meaningful Pain Relief
Subjects evaluated the time to "First Perceptible" 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. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
Measured: 0-6 hours
Secondary outcomes (7)
Pain Intensity Difference (PID) Scores at Each Individual Time Points
PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.
Measured: 0-6 hours
Pain Relief (PR) Scores at Individual Time Points
Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.
Measured: 0-6 hours
Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours
SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).
Measured: 0-2 and 0-6 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points
PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).
Measured: 0-6 hours
Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours
SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).
Measured: 0-2 and 0-6 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours
TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)
Measured: 0-2 and 0-6 hours
Time to First Perceptible Relief
The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740857
- Sponsor's protocol ID
- PV-08-24
- Status last verified
- Jun 2011
- First submitted
- 22 Aug 2008
- Last updated
- 6 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Efficacy of Two Ibuprofen Formulations
- ClinicalTrials.gov ID
- NCT00740857
- Acronym / sponsor ID
- PV-08-24
- Conditions
- Pain
- Keywords
- Dental pain analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Posted 12 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Active comparator | Drug: ibuprofen Formulation 1 |
| 3 | Active comparator | Drug: ibuprofen Formulation 2 |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Outpatients with post-operative pain following surgical extraction of third molars,
- 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 or rescue medication.
- any serious medical condition,
- acute localized dental infection at the time of surgery ,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| placebo2 placebo gels capsules delivered as a single dose. | Drug | 1 |
| ibuprofen Formulation 12 marketed ibuprofen gels | Drug | 2 |
| ibuprofen Formulation 22 marketed ibuprofen gels | Drug | 3 |
Primary outcome
Time to Meaningful Pain Relief
Time frame: 0-6 hours
Subjects evaluated the time to "First Perceptible" 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. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
7 secondary outcomes
Pain Intensity Difference (PID) Scores at Each Individual Time Points
Time frame: 0-6 hours
Pain Relief (PR) Scores at Individual Time Points
Time frame: 0-6 hours
Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours
Time frame: 0-2 and 0-6 hours
Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points
Time frame: 0-6 hours
Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours
Time frame: 0-2 and 0-6 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours
Time frame: 0-2 and 0-6 hours
Time to First Perceptible Relief
Time frame: 0-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibuprofen Formulation 1 and ibuprofen Formulation 2 in people with Pain, run by Wyeth is now a wholly owned subsidiary of 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 7 inclusion and 0 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 Jun 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 12 Aug 2010). 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 to Meaningful Pain Relief (time frame: 0-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2011.