Trial · NCT01075243
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
NCT01075243, Phase 4, Completed, GlaxoSmithKline; results first posted 2015-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy. Trials, record NCT01075243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01075243
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
- NCT number
- NCT01075243
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 401 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Post-surgical Dental Pain
- Interventions
- Paracetamol 1000 mg, Paracetamol 650 mg, Placebo
- First posted
- 2010-02-25
- Last updated
- 2015-04-29
- Results first posted
- 2015-04-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 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 \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\] |
| Secondary | Time to Confirmed First Perceptible Relief | Baseline to 6 hours post dose | 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. |
| Secondary | Time to Onset of Meaningful Pain Relief | Baseline to 6 hours post dose | Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. |
| Secondary | Time to Start Using Rescue Medication | Baseline to 6 hours post dose | Median time of use of rescue medication by participants. |
| Secondary | Percentage of Participants Who Took Rescue Medication at 2 Hours | Baseline to 2 hours post dose | Percentage of participants who received rescue medication at different time points post dose. |
| Secondary | Percentage of Participants Who Took Rescue Medication at 6 Hours | Baseline to 6 hours post dose | Percentage of participants who received rescue medication at different time points post dose. |
| Secondary | SPRID at 2 Hours | Every two hours from baseline to 2 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 -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 |
| Secondary | SPRID at 4 Hours | Every two hours from baseline to 4 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 -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 |
| Secondary | Total Pain Relief Score (TOTPAR) at 2 Hours | Every two hours from baseline to 2 hours post dose | 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 \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\]. |
| Secondary | TOTPAR at 4 Hours | Every two hours from baseline to 4 hours post dose | 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 \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\]. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Every two hours from Baseline to 6 hours post dose | Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. | Score on a scale | MEAN |
| SECONDARY | Time to Confirmed First Perceptible Relief | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | minutes | MEAN |
| SECONDARY | Time to Onset of Meaningful Pain Relief | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | minutes | MEAN |
| SECONDARY | Time to Start Using Rescue Medication | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored. | minutes | MEDIAN |
| SECONDARY | Percentage of Participants Who Took Rescue Medication at 2 Hours | Baseline to 2 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Took Rescue Medication at 6 Hours | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Percentage of participants | NUMBER |
| SECONDARY | SPRID at 2 Hours | Every two hours from baseline to 2 hours post dose | All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | SPRID at 4 Hours | Every two hours from baseline to 4 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | Total Pain Relief Score (TOTPAR) at 2 Hours | Every two hours from baseline to 2 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | TOTPAR at 4 Hours | Every two hours from baseline to 4 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Paracetamol Caplet 1000mg | 16.08 | Standard Deviation 10.68 | Score on a scale | |
| Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Paracetamol Caplet 650 mg | 12.42 | Standard Deviation 9.89 | Score on a scale | |
| Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Placebo Caplet | 4.63 | Standard Deviation 8.82 | Score on a scale | |
| Time to Confirmed First Perceptible Relief | Paracetamol Caplet 1000mg | 54.72 | Standard Deviation 104.911 | minutes | |
| Time to Confirmed First Perceptible Relief | Paracetamol Caplet 650 mg | 69.67 | Standard Deviation 120.501 | minutes | |
| Time to Confirmed First Perceptible Relief | Placebo Caplet | 225.70 | Standard Deviation 162.884 | minutes | |
| Time to Onset of Meaningful Pain Relief | Paracetamol Caplet 1000mg | 70.53 | Standard Deviation 101.474 | minutes | |
| Time to Onset of Meaningful Pain Relief | Paracetamol Caplet 650 mg | 88.16 | Standard Deviation 115.955 | minutes | |
| Time to Onset of Meaningful Pain Relief | Placebo Caplet | 247.14 | Standard Deviation 143.028 | minutes | |
| Time to Start Using Rescue Medication | Paracetamol Caplet 1000 mg | 360.00 | Full Range 124.00 to 360.00 | minutes |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paracetamol Caplet 1000 Milligrams (mg) | 163 | |
| Overall Study | STARTED | Paracetamol Caplet 650 mg | 158 | |
| Overall Study | STARTED | Placebo Caplet | 80 | |
| Overall Study | COMPLETED | Paracetamol Caplet 1000 Milligrams (mg) | 157 | |
| Overall Study | COMPLETED | Paracetamol Caplet 650 mg | 155 | |
| Overall Study | COMPLETED | Placebo Caplet | 80 | |
| Overall Study | NOT COMPLETED | Paracetamol Caplet 1000 Milligrams (mg) | 6 | |
| Overall Study | NOT COMPLETED | Paracetamol Caplet 650 mg | 3 | |
| Overall Study | NOT COMPLETED | Placebo Caplet | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Paracetamol Caplet 1000mg | 17 | 163 | 18 |
| other | Nausea | Gastrointestinal disorders | Paracetamol Caplet 650 mg | 17 | 158 | 17 |
| other | Nausea | Gastrointestinal disorders | Placebo Caplet | 7 | 80 | 8 |
| other | Vomiting | Gastrointestinal disorders | Paracetamol Caplet 1000mg | 7 | 163 | 7 |
| other | Vomiting | Gastrointestinal disorders | Paracetamol Caplet 650 mg | 5 | 158 | 5 |
| other | Vomiting | Gastrointestinal disorders | Placebo Caplet | 4 | 80 | 4 |
| other | Headache | Nervous system disorders | Paracetamol Caplet 1000mg | 4 | 163 | 4 |
| other | Headache | Nervous system disorders | Paracetamol Caplet 650 mg | 6 | 158 | 6 |
| other | Headache | Nervous system disorders | Placebo Caplet | 7 | 80 | 7 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paracetamol Caplet 1000mg | ||
| Total, all-cause mortality | Paracetamol Caplet 650 mg | ||
| Total, all-cause mortality | Placebo Caplet | ||
| Total, other adverse events | Paracetamol Caplet 1000mg | 28 | 163 |
| Total, other adverse events | Paracetamol Caplet 650 mg | 28 | 158 |
| Total, other adverse events | Placebo Caplet | 18 | 80 |
| Total, serious adverse events | Paracetamol Caplet 1000mg | 0 | 163 |
| Total, serious adverse events | Paracetamol Caplet 650 mg | 0 | 158 |
| Total, serious adverse events | Placebo Caplet | 0 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23972577 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01075243
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