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Ibuprofen Extended-Release Dental Pain Study

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ClinicalTrials.gov Identifier: NCT00707057
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : March 23, 2011
Last Update Posted : March 24, 2011
Sponsor:
Collaborators:
AAIPharma
Jean Brown Research
Information provided by:
SCOLR Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Post-Operative Pain
Third Molar Extraction
Interventions Drug: Ibuprofen 600 mg Extended-Release Tablets
Drug: Placebo
Enrollment 256
Recruitment Details Date First Subject Enrolled: 24 June 2008 Date Last Subject Enrolled: 11 October 2008 All subjects were to receive 4 doses of study drug or placebo at 12-hour intervals. Of the 12 subjects who prematurely discontinued study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.
Pre-assignment Details  
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description Participants received 600 mg 12-hour extended-release tablets twice daily (BID). Participants received placebo tablet twice daily (BID)
Period Title: Overall Study
Started 169 87
Completed 161 83
Not Completed 8 4
Reason Not Completed
Withdrawal by Subject             8             3
Dosed incorrectly             0             1
Arm/Group Title Ibuprofen 600mg ER Placebo Total
Hide Arm/Group Description Participants received 600 mg 12-hour extended-release tablets twice daily (BID). Participants received placebo tablet twice daily (BID) Total of all reporting groups
Overall Number of Baseline Participants 169 87 256
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 87 participants 256 participants
<=18 years
64
  37.9%
35
  40.2%
99
  38.7%
Between 18 and 65 years
105
  62.1%
52
  59.8%
157
  61.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants 87 participants 256 participants
18.9  (3.22) 18.8  (3.25) 18.9  (3.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 87 participants 256 participants
Female
95
  56.2%
47
  54.0%
142
  55.5%
Male
74
  43.8%
40
  46.0%
114
  44.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 169 participants 87 participants 256 participants
169 87 256
1.Primary Outcome
Title Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale
Hide Description

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.

Time Frame from baseline to 12 hours after dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
14.80  (16.331) 0.40  (11.933)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and >7).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame 24, 36, and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Measure Type: Number
Unit of Measure: participants
123 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Time to Confirmed "First Perceptible" Relief
Hide Description 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.
Time Frame Within 4 hours post Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Median (Full Range)
Unit of Measure: Minutes
42.00
(4 to 81)
240
(240 to 240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Time to Confirmed "Meaningful" Relief
Hide Description 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.
Time Frame Within 4 hours post Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Median (Full Range)
Unit of Measure: Minutes
108
(18 to 240)
240
(240 to 240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1
Hide Description 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.
Time Frame Within 1 hour of Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
62
(54 to 69)
12
(5 to 18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief
Hide Description 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
Time Frame Within 4 hours post Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
69
(62 to 76)
17
(9 to 25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame 0-12 hours after Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Time weighted units on a scale
TOTPAR 0-12 hours 54.59  (40.830) 12.05  (27.114)
TOTPAR 0-4 hours 16.84  (11.854) 3.18  (6.749)
TOTPAR 4-8 hours 25.94  (19.013) 5.34  (12.393)
TOTPAR 4-12 hours 43.38  (33.851) 9.92  (23.411)
SPID 0-12 hours 37.20  (34.791) 0.45  (24.378)
SPID 0-4 hours 11.64  (10.222) -0.18  (6.591)
SPID 4-8 hours 17.88  (16.158) 0.24  (11.034)
SPID 4-12 hours 29.49  (28.654) 0.67  (20.617)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval 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. Time weighted TOTPAR for ech specified interval was similarly derived.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and >7.
8.Secondary Outcome
Title Duration of Relief After Dose 1
Hide Description 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.
Time Frame Time to rescue or time of Dose 2 (up to 12 hours following dose 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Median (Full Range)
Unit of Measure: Minutes
720
(1 to 720)
101
(1 to 720)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1
Hide Description 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.
Time Frame 0-12 hours after taking Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
Rescue at or prior to 8 hours after dose 1
31.4
(24 to 38)
82.8
(75 to 91)
Rescue at or prior to 10 hours after dose 1
34.9
(28 to 42)
85.1
(78 to 93)
Rescue at or prior to 12 hours after dose 1
36.1
(29 to 43)
85.1
(78 to 93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Pain Relief and PID Scores at Individual Time Points for Dose 1
Hide Description 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)
Time Frame 24, 36, 48 hours after taking Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
24 hours after dose 1. 3.11  (3.466) 0.18  (2.599)
36 hours after dose 1. 3.10  (3.460) 0.22  (2.704)
48 hours after dose 1. 3.44  (3.756) 0.22  (2.721)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Global Evaluation for Dose 1
Hide Description

Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:

“Select the number that best describes how you would rate this medication as a pain-reliever (select one number only).” The range went from 0 (Very poor) to 10 (Excellent).

Time Frame At 12 hours after Dose 1 or at time of rescue
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.05  (3.536) 1.79  (2.898)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Global Evaluation, Maximum Relief, and Overall Relief for Dose 2
Hide Description Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief).
Time Frame At 24 hours or at time of rescue between 12 and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Global Evalution for Dose 2 6.82  (2.914) 4.24  (3.673)
Maximum Relief for Dose 2 7.27  (2.997) 5.02  (3.864)
Overall Relief for Dose 2 6.62  (3.005) 4.46  (3.588)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments

Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.

The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments

Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.

The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments

Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.

The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Global Evaluation, Maximum Relief, and Overall Relief for Dose 3
Hide Description Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief).
Time Frame At 36 hours or at time rescue between 24 and 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Global Evaluation for Dose 3 7.14  (2.839) 4.98  (3.549)
Maximum Relief for Dose 3 7.61  (2.922) 5.63  (3.805)
Overall Relief for Dose 3 6.76  (2.942) 5.02  (3.634)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and basee pain score categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Global Evaluation, Maximum Relief, and Overall Relief for Dose 4
Hide Description Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: "rate the study medication as a pain-reliever"; Maximum Pain Relief: "maximum pain relief received from the last dose"; Overall Pain Relief: "overall quantity of pain relief received from the last dose". The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief).
Time Frame At 48 hours or at time of rescue between 36 and 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description:
Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Participants received placebo tablet twice daily (BID)
Overall Number of Participants Analyzed 169 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Global Evalution for Dose 4 7.26  (2.953) 4.70  (3.715)
Maximum Relief for Dose 4 7.66  (2.970) 5.34  (3.970)
Overall Relief for Dose 4 7.06  (3.045) 4.89  (3.803)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 600mg ER, Placebo
Comments Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibuprofen 600mg ER Placebo
Hide Arm/Group Description Participants received 600 mg 12-hour extended-release tablets twice daily (BID). Participants received placebo tablet twice daily (BID)
All-Cause Mortality
Ibuprofen 600mg ER Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen 600mg ER Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)   0/87 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.35%
Ibuprofen 600mg ER Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)   0/87 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Turner, VP and Chief Technical Officer
Organization: SCOLR Pharma Inc
Phone: 425-368-1050 ext 1001
EMail: sturner@scolr.com
Layout table for additonal information
Responsible Party: Stephen Turner, President & CEO, SCOLR Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00707057     History of Changes
Other Study ID Numbers: SCO-0001
First Submitted: June 26, 2008
First Posted: June 30, 2008
Results First Submitted: May 21, 2009
Results First Posted: March 23, 2011
Last Update Posted: March 24, 2011