PainPhase 4NCT00240864
An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain
A Phase 4 study testing acetaminophen and ibuprofen in people with Pain, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pain
- What is being tested?
- acetaminophen and ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2004
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indicates moderate to severe pain following the extraction of at least three molars (including at least one partial or complete bony mandibular third molar impaction)
- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28
- not taking any medications for anxiety, depression or schizophrenia
- if female, not pregnant or breastfeeding
Who cannot join
- Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other pain relievers or anti-inflammatory drugs within 24 hours preceding surgery
- have any gastrointestinal disease that would interfere with the absorption and excretion of study medications
- unable to swallow the study medication whole
- have any significant medical condition
- have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic agent used in the extraction
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain
The purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars.
Read the detailed description
The primary objective of this randomized, double-blind, placebo-controlled study is to determine the onset of analgesia following the administration of a single dose of 1000 mg of acetaminophen, 400 mg of ibuprofen or placebo in subjects experiencing acute postoperative dental pain secondary to the surgical extraction of at least three molars, with at least one being a partial or complete bony mandibular third molar impaction. After reporting moderate to severe pain following dental surgery, subjects record their baseline pain intensity and are treated with a single oral dose of acetaminophen, ibuprofen, or placebo. Subjects evaluate their pain intensity and pain relief relative to baseline at various timepoints up to 4 hours after taking study medication. Pain intensity is assessed using a five-point scale consisting of none (0), mild (1), moderate (2), moderately severe (3), and severe (4). Pain relief from baseline is evaluated on a five-point scale consisting of none (0), a little (1), some (2), a lot (3), and complete (4). At the end of the first hour of the observation period or at the time of taking supplemental analgesic medication (rescue treatment), whichever occurs first, subjects make an overall (global) assessment of the study medication, based on a five-point scale consisting of poor (0), fair (1), good (2), very good (3), or excellent (4). Subjects are required to remain at the study site for the duration of the four-hour observation period. The primary efficacy assessments are pain intensity differences from baseline and pain relief at each measurement time. Safety is assessed by monitoring adverse events occuring throughout the study. The primary hypotheses are that there is a difference between acetaminophen and placebo and between ibuprofen and placebo at some time point for the proportion of subjects reporting non-zero pain relief. The patients receive a single oral dose of one of the following three treatments: Two acetaminophen 500 mg caplets and two placebo ibuprofen capsules, two placebo acetaminophen caplets and two ibuprofen 200 mg capsules, or two placebo acetaminophen caplets and two placebo ibuprofen capsules.
- Conditions
- Pain
- Being tested
- placebo, acetaminophen, ibuprofen
- Keywords
- postoperative dental pain, acetaminophen, ibuprofen
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
acetaminophenDrug
ibuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | acetaminophen Receives: Drug: acetaminophen |
| 002 | Experimental | ibuprofen Receives: Drug: ibuprofen |
| 003 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time at which the proportion of subjects indicating non-zero pain relief for each active treatment becomes statistically significantly superior to placebo.
Secondary outcomes (1)
Pain intensity differences from baseline and pain relief at each measurement time; Area under the curve of pain relief scores at1 hour (TOTPAR1); Pain intensity differences at 1 hour (SPID1); Subjects' global assessment of pain relief at one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study completionFeb 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Responsible party
- Sponsor
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240864
- Sponsor's protocol ID
- CR002671
- Status last verified
- Jun 2015
- First submitted
- 14 Oct 2005
- Last updated
- 19 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain
- ClinicalTrials.gov ID
- NCT00240864
- Acronym / sponsor ID
- CR002671
- Conditions
- Pain
- Keywords
- postoperative dental pain, acetaminophen, ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Collaborators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Study completion
- Feb 2004 (actual)
- First posted
- 18 Oct 2005 (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 purpose of this study is to determine the onset of pain relief from a single dose of acetaminophen and ibuprofen in subjects experiencing postoperative dental pain following the surgical extraction of at least three molars.
Detailed description
The primary objective of this randomized, double-blind, placebo-controlled study is to determine the onset of analgesia following the administration of a single dose of 1000 mg of acetaminophen, 400 mg of ibuprofen or placebo in subjects experiencing acute postoperative dental pain secondary to the surgical extraction of at least three molars, with at least one being a partial or complete bony mandibular third molar impaction. After reporting moderate to severe pain following dental surgery, subjects record their baseline pain intensity and are treated with a single oral dose of acetaminophen, ibuprofen, or placebo. Subjects evaluate their pain intensity and pain relief relative to baseline at various timepoints up to 4 hours after taking study medication. Pain intensity is assessed using a five-point scale consisting of none (0), mild (1), moderate (2), moderately severe (3), and severe (4). Pain relief from baseline is evaluated on a five-point scale consisting of none (0), a little (1), some (2), a lot (3), and complete (4). At the end of the first hour of the observation period or at the time of taking supplemental analgesic medication (rescue treatment), whichever occurs first, subjects make an overall (global) assessment of the study medication, based on a five-point scale consisting of poor (0), fair (1), good (2), very good (3), or excellent (4). Subjects are required to remain at the study site for the duration of the four-hour observation period. The primary efficacy assessments are pain intensity differences from baseline and pain relief at each measurement time. Safety is assessed by monitoring adverse events occuring throughout the study. The primary hypotheses are that there is a difference between acetaminophen and placebo and between ibuprofen and placebo at some time point for the proportion of subjects reporting non-zero pain relief. The patients receive a single oral dose of one of the following three treatments: Two acetaminophen 500 mg caplets and two placebo ibuprofen capsules, two placebo acetaminophen caplets and two ibuprofen 200 mg capsules, or two placebo acetaminophen caplets and two placebo ibuprofen capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: acetaminophenacetaminophen |
| 002 | Experimental | Drug: ibuprofenibuprofen |
| 003 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Indicates moderate to severe pain following the extraction of at least three molars (including at least one partial or complete bony mandibular third molar impaction)
- weighs at least 100 pounds and has a Body Mass Index (BMI) between 18 and 28
- not taking any medications for anxiety, depression or schizophrenia
- if female, not pregnant or breastfeeding
Key exclusion criteria (5 listed)
- Used ibuprofen or acetaminophen within 12 hours preceding surgery or any other pain relievers or anti-inflammatory drugs within 24 hours preceding surgery
- have any gastrointestinal disease that would interfere with the absorption and excretion of study medications
- unable to swallow the study medication whole
- have any significant medical condition
- have a history of adverse reactions to acetaminophen, ibuprofen or any anesthetic agent used in the extraction
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 |
|---|---|---|
| placebo | Drug | 003 |
| acetaminophen | Drug | 001 |
| ibuprofen | Drug | 002 |
Primary outcome
Time at which the proportion of subjects indicating non-zero pain relief for each active treatment becomes statistically significantly superior to placebo.
1 secondary outcome
Pain intensity differences from baseline and pain relief at each measurement time; Area under the curve of pain relief scores at1 hour (TOTPAR1); Pain intensity differences at 1 hour (SPID1); Subjects' global assessment of pain relief at one hour
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 19 Jun 2015.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen and ibuprofen in people with Pain, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 4 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 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time at which the proportion of subjects indicating non-zero pain relief for each active treatment becomes statistically significantly superior to placebo.. 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 19 Jun 2015.