Trial · NCT00707057
Ibuprofen Extended-Release Dental Pain Study
NCT00707057, Phase 3, Completed, SCOLR Pharma, Inc.; results first posted 2011-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibuprofen Extended-Release Dental Pain Study. Trials, record NCT00707057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00707057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibuprofen Extended-Release Dental Pain Study
- NCT number
- NCT00707057
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- SCOLR Pharma, Inc.
- Conditions
- Pain, Post-Operative Pain, Third Molar Extraction
- Interventions
- Ibuprofen 600 mg Extended-Release Tablets, Placebo
- First posted
- 2008-06-30
- Last updated
- 2011-03-24
- Results first posted
- 2011-03-23
- Limitations and caveats
- Of the 12 subjects who prematurely discontinued all 4 doses of the study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | from baseline to 12 hours after dose 1 | Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID). An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation. |
| Primary | Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | 24, 36, and 48 hours | Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation. |
| Secondary | Time to Confirmed "First Perceptible" Relief | Within 4 hours post Dose 1 | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for "No Pain Relief" is 240 minutes. |
| Secondary | Time to Confirmed "Meaningful" Relief | Within 4 hours post Dose 1 | When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when "initial" relief was observed and again when "meaningful" relief was achieved. Time to confirmed "meaningful" relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both "initial" and "meaningful" relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain. |
| Secondary | Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Within 1 hour of Dose 1 | Percentage (percentage of total) of subjects with "first perceptible" relief within 1 hour of Dose 1. The assigned censored time for "No Pain Relief" was 240 minutes. |
| Secondary | Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief | Within 4 hours post Dose 1 | Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both "first perceptible" relief and "meaningful" relief within the time allotted. The assigned censored time for "No Pain Relief" is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain |
| Secondary | Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID) | 0-12 hours after Dose 1 | The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived. |
| Secondary | Duration of Relief After Dose 1 | Time to rescue or time of Dose 2 (up to 12 hours following dose 1) | Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time. |
| Secondary | Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1 | 0-12 hours after taking Dose 1 | Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated. |
| Secondary | Pain Relief and PID Scores at Individual Time Points for Dose 1 | 24, 36, 48 hours after taking Dose 1 | Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | from baseline to 12 hours after dose 1 | Intention to treat (ITT) | Units on a scale | MEAN |
| PRIMARY | Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | 24, 36, and 48 hours | Intention to treat (ITT) | participants | NUMBER |
| SECONDARY | Time to Confirmed First Perceptible Relief | Within 4 hours post Dose 1 | Intention to treat (ITT) | Minutes | MEDIAN |
| SECONDARY | Time to Confirmed Meaningful Relief | Within 4 hours post Dose 1 | Intention to treat (ITT) | Minutes | MEDIAN |
| SECONDARY | Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Within 1 hour of Dose 1 | Intention to treat (ITT) | Percent of participants | NUMBER |
| SECONDARY | Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief | Within 4 hours post Dose 1 | Intention to treat (ITT) | Percent of participants | NUMBER |
| SECONDARY | Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID) | 0-12 hours after Dose 1 | Intention to treat (ITT) | Time weighted units on a scale | MEAN |
| SECONDARY | Duration of Relief After Dose 1 | Time to rescue or time of Dose 2 (up to 12 hours following dose 1) | Intention to treat (ITT) | Minutes | MEDIAN |
| SECONDARY | Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1 | 0-12 hours after taking Dose 1 | Intention to treat (ITT) | Percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Relief and PID Scores at Individual Time Points for Dose 1 | 24, 36, 48 hours after taking Dose 1 | Intention to treat (ITT) | Units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | Ibuprofen 600mg ER | 14.80 | Standard Deviation 16.331 | Units on a scale | |
| Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale | Placebo | 0.40 | Standard Deviation 11.933 | Units on a scale | |
| Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | Ibuprofen 600mg ER | 123 | participants | ||
| Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | Placebo | 47 | participants | ||
| Time to Confirmed First Perceptible Relief | Ibuprofen 600mg ER | 42.00 | Full Range 4 to 81 | Minutes | |
| Time to Confirmed First Perceptible Relief | Placebo | 240 | Full Range 240 to 240 | Minutes | |
| Time to Confirmed Meaningful Relief | Ibuprofen 600mg ER | 108 | Full Range 18 to 240 | Minutes | |
| Time to Confirmed Meaningful Relief | Placebo | 240 | Full Range 240 to 240 | Minutes | |
| Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Ibuprofen 600mg ER | 62 | 95% Confidence Interval 54 to 69 | Percent of participants | |
| Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1 | Placebo | 12 | 95% Confidence Interval 5 to 18 | Percent of participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen 600mg ER | 169 | |
| Overall Study | STARTED | Placebo | 87 | |
| Overall Study | COMPLETED | Ibuprofen 600mg ER | 161 | |
| Overall Study | COMPLETED | Placebo | 83 | |
| Overall Study | NOT COMPLETED | Ibuprofen 600mg ER | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen 600mg ER | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ibuprofen 600mg ER | 0 | 169 |
| Total, other adverse events | Placebo | 0 | 87 |
| Total, serious adverse events | Ibuprofen 600mg ER | 0 | 169 |
| Total, serious adverse events | Placebo | 0 | 87 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ibuprofen 600mg ER vs Placebo: Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours | Trial comparisons |
| Ibuprofen 600mg ER vs Placebo: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00707057
GET https://conductscience.org/api/trials/v1/NCT00707057/results?page=2