PainPhase 3NCT00631111
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
A Phase 3 study testing effervescent ibuprofen tablets, effervescent Aspirin plus Vitamin C tablets and ibuprofen tablets in people with Pain, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets. 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?
- effervescent ibuprofen tablets, effervescent Aspirin plus Vitamin C tablets and ibuprofen tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
- Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide
Who cannot join
- Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
- Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
- Conditions
- Pain
- Being tested
- effervescent ibuprofen tablets, effervescent Aspirin plus Vitamin C tablets, ibuprofen tablets, placebo
- Keywords
- dental pain, analgesic, NSAID, ibuprofen, aspirin
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
effervescent ibuprofen tabletsDrug
effervescent Aspirin plus Vitamin C tabletsDrug
ibuprofen tabletsDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: effervescent ibuprofen tablets |
| 2 | Active comparator | Not described Receives: Drug: effervescent Aspirin plus Vitamin C tablets |
| 3 | Active comparator | Not described Receives: Drug: ibuprofen tablets |
| 4 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of pain relief and pain intensity difference scores
Measured: 8 hours
Secondary outcomes (1)
Time to meaningful pain relief
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 270 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
- NCT00631111
- Sponsor's protocol ID
- AI-07-02
- Status last verified
- Jul 2009
- First submitted
- 28 Feb 2008
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
- ClinicalTrials.gov ID
- NCT00631111
- Acronym / sponsor ID
- AI-07-02
- Conditions
- Pain
- Keywords
- dental pain, analgesic, NSAID, ibuprofen, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 7 Mar 2008 (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.
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: effervescent ibuprofen tablets |
| 2 | Active comparator | Drug: effervescent Aspirin plus Vitamin C tablets |
| 3 | Active comparator | Drug: ibuprofen tablets |
| 4 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
- Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide
Key exclusion criteria (3 listed)
- Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
- Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
- 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
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 |
|---|---|---|
| effervescent ibuprofen tablets | Drug | 1 |
| effervescent Aspirin plus Vitamin C tablets | Drug | 2 |
| ibuprofen tablets | Drug | 3 |
| placebo | Drug | 4 |
Primary outcome
Sum of pain relief and pain intensity difference scores
Time frame: 8 hours
1 secondary outcome
Time to meaningful pain relief
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
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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 3 study testing effervescent ibuprofen tablets, effervescent Aspirin plus Vitamin C tablets and ibuprofen tablets 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 3 inclusion and 3 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 10 Aug 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sum of pain relief and pain intensity difference scores (time frame: 8 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 10 Aug 2009.