Post-operative PainPhase 3NCT01229449
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
A Phase 3 study testing Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose) and Nurofen Plus® in people with Post-operative Pain, run by Reckitt Benckiser LLC at 1 site in United States.
Trial summary
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose) and Nurofen Plus®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
Experiencing moderate to severe pain after extraction of impacted third molars
Main Exclusion Criteria:
Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
Read the detailed description
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators.
The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.
The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.
- Conditions
- Post-operative Pain
- Being tested
- Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose), Nurofen Plus®, Panadeine® Extra, Placebo
- Keywords
- Dental pain, Ibuprofen, Acetaminophen, Nurofen Plus®, Panadeine® Extra, Paracetamol
- Medical subject headings
- Pain, Postoperative, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen/acetaminophenDrug
Also called Ibuprofen/paracetamol (lower dose)
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
Ibuprofen/acetaminophen (higher dose)Drug
Also called Ibuprofen/Paracetamol
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
Nurofen Plus®Drug
Also called Ibuprofen/Codeine
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
Panadeine® ExtraDrug
Also called Acetaminophen/codeine, Paracetamol/codeine
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
PlaceboDrug
Two placebo tablets, single dose taken orally with 300 ml water
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen/acetaminophen (lower dose) | Experimental | One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet Receives: Drug: Ibuprofen/acetaminophen |
| Ibuprofen/acetaminophen (higher dose) | Experimental | Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg Receives: Drug: Ibuprofen/acetaminophen (higher dose) |
| Nurofen Plus® | Active comparator | Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) Receives: Drug: Nurofen Plus® |
| Panadeine® Extra | Active comparator | Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) Receives: Drug: Panadeine® Extra |
| Placebo | Placebo comparator | Two placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Measured: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Secondary outcomes (9)
Change From Baseline in AUC (0-8h) of SPRID
SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Measured: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Measured: 0-4, 0-6, 0-8 and 0-12 hours
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'
Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Measured: 0-4, 0-6, 0-8 and 0-12 hours
Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Individual Pain Intensity Differences (Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'
PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.'
Measured: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'
PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Measured: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Change From Baseline in Peak Pain Relief (PR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'
Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Measured: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?'
Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent.
Measured: At 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 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 Post-operative 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Aptuit
- Responsible party
- Sponsor
- Investigators
- Stephen Daniels, Principal investigator, Premier Research Group Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229449
- Sponsor's protocol ID
- NL0811
- Status last verified
- Aug 2018
- First submitted
- 26 Oct 2010
- Last updated
- 17 Sep 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 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
- ClinicalTrials.gov ID
- NCT01229449
- Acronym / sponsor ID
- NL0811
- Conditions
- Post-operative Pain
- Keywords
- Dental pain, Ibuprofen, Acetaminophen, Nurofen Plus®, Panadeine® Extra, Paracetamol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 678 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research, Aptuit
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Posted 17 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
Detailed description
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators.
The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.
The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen/acetaminophen (lower dose) | Experimental | Drug: Ibuprofen/acetaminophenOne tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet |
| Ibuprofen/acetaminophen (higher dose) | Experimental | Drug: Ibuprofen/acetaminophen (higher dose)Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg |
| Nurofen Plus® | Active comparator | Drug: Nurofen Plus®Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) |
| Panadeine® Extra | Active comparator | Drug: Panadeine® ExtraTwo tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo tablets |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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/acetaminophenAlso: Ibuprofen/paracetamol (lower dose)One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water | Drug | Ibuprofen/acetaminophen (lower dose) |
| Ibuprofen/acetaminophen (higher dose)Also: Ibuprofen/ParacetamolTwo tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water | Drug | Ibuprofen/acetaminophen (higher dose) |
| Nurofen Plus®Also: Ibuprofen/CodeineTwo tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water | Drug | Nurofen Plus® |
| Panadeine® ExtraAlso: Acetaminophen/codeine, Paracetamol/codeineTwo tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water | Drug | Panadeine® Extra |
| PlaceboTwo placebo tablets, single dose taken orally with 300 ml water | Drug | Placebo |
Primary outcome
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
9 secondary outcomes
Change From Baseline in AUC (0-8h) of SPRID
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
Time frame: 0-4, 0-6, 0-8 and 0-12 hours
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
Time frame: 0-4, 0-6, 0-8 and 0-12 hours
Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Individual Pain Intensity Differences (Ordinal)
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Change From Baseline in Peak Pain Relief (PR)
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
Time frame: At 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- 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.
Stephen Daniels principal investigator
Premier Research Group Inc
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 Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose) and Nurofen Plus® in people with Post-operative Pain, run by Reckitt Benckiser LLC 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?
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 17 Sep 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 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 17 Sep 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?
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) (time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose). 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 17 Sep 2018.