Ibuprofen Extended-Release Dental Pain Study

This study has been completed.
Sponsor:
Collaborators:
AAIPharma
Jean Brown Research
Information provided by:
SCOLR Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00707057
First received: June 26, 2008
Last updated: March 22, 2011
Last verified: March 2011
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
Post-Operative Pain
Third Molar Extraction
Interventions: Drug: Ibuprofen 600 mg Extended-Release Tablets
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ibuprofen 600mg ER Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Placebo Participants received placebo tablet twice daily (BID)

Participant Flow:   Overall Study
    Ibuprofen 600mg ER     Placebo  
STARTED     169     87  
COMPLETED     161     83  
NOT COMPLETED     8     4  
Withdrawal by Subject                 8                 3  
Dosed incorrectly                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ibuprofen 600mg ER Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
Placebo Participants received placebo tablet twice daily (BID)
Total Total of all reporting groups

Baseline Measures
    Ibuprofen 600mg ER     Placebo     Total  
Number of Participants  
[units: participants]
  169     87     256  
Age  
[units: participants]
     
<=18 years     64     35     99  
Between 18 and 65 years     105     52     157  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  18.9  ± 3.22     18.8  ± 3.25     18.9  ± 3.22  
Gender  
[units: participants]
     
Female     95     47     142  
Male     74     40     114  
Region of Enrollment  
[units: participants]
     
United States     169     87     256  



  Outcome Measures
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1.  Primary:   Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale   [ Time Frame: from baseline to 12 hours after dose 1 ]

2.  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   [ Time Frame: 24, 36, and 48 hours ]

3.  Secondary:   Time to Confirmed "First Perceptible" Relief   [ Time Frame: Within 4 hours post Dose 1 ]

4.  Secondary:   Time to Confirmed "Meaningful" Relief   [ Time Frame: Within 4 hours post Dose 1 ]

5.  Secondary:   Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1   [ Time Frame: Within 1 hour of Dose 1 ]

6.  Secondary:   Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief   [ Time Frame: Within 4 hours post Dose 1 ]

7.  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)   [ Time Frame: 0-12 hours after Dose 1 ]

8.  Secondary:   Duration of Relief After Dose 1   [ Time Frame: Time to rescue or time of Dose 2 (up to 12 hours following dose 1) ]

9.  Secondary:   Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1   [ Time Frame: 0-12 hours after taking Dose 1 ]

10.  Secondary:   Pain Relief and PID Scores at Individual Time Points for Dose 1   [ Time Frame: 24, 36, 48 hours after taking Dose 1 ]

11.  Secondary:   Global Evaluation for Dose 1   [ Time Frame: At 12 hours after Dose 1 or at time of rescue ]

12.  Secondary:   Global Evaluation, Maximum Relief, and Overall Relief for Dose 2   [ Time Frame: At 24 hours or at time of rescue between 12 and 24 hours ]

13.  Secondary:   Global Evaluation, Maximum Relief, and Overall Relief for Dose 3   [ Time Frame: At 36 hours or at time rescue between 24 and 36 hours ]

14.  Secondary:   Global Evaluation, Maximum Relief, and Overall Relief for Dose 4   [ Time Frame: At 48 hours or at time of rescue between 36 and 48 hours. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Stephen Turner, VP and Chief Technical Officer
Organization: SCOLR Pharma Inc
phone: 425-368-1050 ext 1001
e-mail: sturner@scolr.com


No publications provided


Responsible Party: Stephen Turner, President & CEO, SCOLR Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00707057     History of Changes
Other Study ID Numbers: SCO-0001
Study First Received: June 26, 2008
Results First Received: May 21, 2009
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration