Post-surgical Dental PainPhase 4NCT01082081

Post-operative Dental Pain Study Comparing Analgesic Efficacy

A Phase 4 study testing Paracetamol 1000 mg and Paracetamol 500 mg in people with Post-surgical Dental Pain, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Post-surgical Dental Pain
What is being tested?: Paracetamol 1000 mg and Paracetamol 500 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 2 sitesUnited States
Study dates: Oct 2009to Mar 2010
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 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PPD Dental Clinic
Austin, Texas, 78744
Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief

GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Conditions: Post-surgical Dental Pain
Being tested: Paracetamol 1000 mg, Paracetamol 500 mg, Placebo
Keywords: paracetamol, dental pain, Post-surgical dental pain
Medical subject headings: Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paracetamol 1000 mgDrug
Paracetamol 1000 mg
Paracetamol 500 mgDrug
Paracetamol 500 mg
PlaceboDrug
Placebo

Study groups in NCT01082081
Study group	Role	What they receive
Paracetamol 1000 mg	Experimental	Paracetamol 1000 mg Receives: Drug: Paracetamol 1000 mg
Paracetamol 500 mg	Experimental	Paracetamol 500 mg Receives: Drug: Paracetamol 500 mg
Placebo	Placebo comparator	Placebo 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 Differences From 0 to 6 Hours (SPRID 6 Hours)
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]
Measured: Every two hours from baseline to 6 hours post dose

Secondary outcomes (14)

Time to Confirmed First Perceptible Pain Relief
Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Measured: Baseline to 6 hours post dose
Time to Onset of Meaningful Pain Relief
Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
Measured: Baseline to 6 hours post dose
Time to Start Using Rescue Medication
Median time of use of rescue medication by participants was calculated.
Measured: Baseline to 6 hours post dose
Percentage of Participants Who Took Rescue Medication Within 2 Hours
Percentage of participants who received rescue medication within 2 hours
Measured: Baseline to 2 hours post dose
Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours
Percentage of participants who took rescue medication during 2 to 6 hours
Measured: Within 2 to 6 hours post dose
SPRID at 2 Hours
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]
Measured: Every two hours from baseline to 2 hours post dose
SPRID at 4 Hours
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]
Measured: Every two hours from baseline to 4 hours post dose
Total Pain Relief (TOTPAR) at 2 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet - timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
Measured: Every two hours from baseline to 2 hours post dose
TOTPAR at 4 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet - timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
Measured: Every two hours from baseline to 4 hours post dose
TOTPAR at 6 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.
TOTPARt = ∑PR x (timet - timet-1).
PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
Measured: Every two hours from baseline to 6 hours post dose
Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Measured: Every two hours from baseline to 2 hours post dose
SPID Scores at 4 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Measured: Every two hours from baseline to 4 hours post dose
SPID Scores at 6 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.
SPIDt = ∑PID x (timet - timet-1)
Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.
If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Measured: Every two hours from baseline to 6 hours post dose
Participants Global Assessment to Response to Treatment (PGART)
PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.
Measured: Baseline to 6 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Mar 2010

First posted8 Mar 2010 (estimated)
Study startOct 2009
Primary completionMar 2010
Study completionMar 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Post-surgical Dental PainStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01082081
Sponsor's protocol ID: A4000684
Status last verified: Mar 2015
First submitted: 18 Feb 2010
Last updated: 13 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.
PubMed 23972577

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief
ClinicalTrials.gov ID: NCT01082081
Acronym / sponsor ID: A4000684
Conditions: Post-surgical Dental Pain
Keywords: paracetamol, dental pain, Post-surgical dental pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 8 Mar 2010 (estimated)
Results: Posted 22 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Paracetamol 1000 mg	Experimental	Drug: Paracetamol 1000 mgParacetamol 1000 mg
Paracetamol 500 mg	Experimental	Drug: Paracetamol 500 mgParacetamol 500 mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.

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
Paracetamol 1000 mgParacetamol 1000 mg	Drug	Paracetamol 1000 mg
Paracetamol 500 mgParacetamol 500 mg	Drug	Paracetamol 500 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
Time frame: Every two hours from baseline to 6 hours post dose
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]

14 secondary outcomes

Time to Confirmed First Perceptible Pain Relief
Time frame: Baseline to 6 hours post dose
Time to Onset of Meaningful Pain Relief
Time frame: Baseline to 6 hours post dose
Time to Start Using Rescue Medication
Time frame: Baseline to 6 hours post dose
Percentage of Participants Who Took Rescue Medication Within 2 Hours
Time frame: Baseline to 2 hours post dose
Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours
Time frame: Within 2 to 6 hours post dose
SPRID at 2 Hours
Time frame: Every two hours from baseline to 2 hours post dose
SPRID at 4 Hours
Time frame: Every two hours from baseline to 4 hours post dose
Total Pain Relief (TOTPAR) at 2 Hours
Time frame: Every two hours from baseline to 2 hours post dose
TOTPAR at 4 Hours
Time frame: Every two hours from baseline to 4 hours post dose
TOTPAR at 6 Hours
Time frame: Every two hours from baseline to 6 hours post dose
Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
Time frame: Every two hours from baseline to 2 hours post dose
SPID Scores at 4 Hours
Time frame: Every two hours from baseline to 4 hours post dose
SPID Scores at 6 Hours
Time frame: Every two hours from baseline to 6 hours post dose
Participants Global Assessment to Response to Treatment (PGART)
Time frame: Baseline to 6 hours post dose

Results and safety

Results posted to the registry on 22 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracetamol Caplet 1000 Milligrams (mg)	121	121
Paracetamol Caplet 500 mg	119	118
Placebo Caplet	60	58

Primary outcome: Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

Time frame: Every two hours from baseline to 6 hours post dose. Mean (Standard Deviation). Unit: Units on a scale

Measure	Paracetamol Caplet 1000 mg n = 121	Paracetamol Caplet 500 mg n = 119	Placebo Caplet n = 60
Value	10.60 (11.75)	5.87 (9.03)	3.35 (9.67)

Paracetamol Caplet 1000 mg vs Paracetamol Caplet 500 mg: Adjusted Mean Difference: 4.77 (95% CI 2.15 to 7.39), p = 0.0004, ANCOVA
Paracetamol Caplet 1000 mg vs Placebo Caplet: Adjusted Mean Difference: 7.25 (95% CI 4.04 to 10.45), p <0.0001, ANCOVA
Paracetamol Caplet 500 mg vs Placebo Caplet: Adjusted Mean Difference: 2.48 (95% CI -0.74 to 5.69), p = 0.1307, ANCOVA

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paracetamol Caplet 1000 mg	0 of 121 (0%)	32 of 121 (26.4%)	Not reported
Paracetamol Caplet 500 mg	0 of 119 (0%)	25 of 119 (21%)	Not reported
Placebo Caplet	0 of 60 (0%)	9 of 60 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23972577Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.

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.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paracetamol 1000 mg and Paracetamol 500 mg in people with Post-surgical Dental Pain, run by GlaxoSmithKline at 2 sites 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 1 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 22 Jan 2015). 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?

Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) (time frame: Every two hours from baseline to 6 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01082081, which also lists 1 linked publication.

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 13 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.