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A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain (SDDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912650
Recruitment Status : Completed
First Posted : September 23, 2016
Results First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 7, 2016
First Posted Date  ICMJE September 23, 2016
Results First Submitted Date  ICMJE June 28, 2017
Results First Posted Date  ICMJE August 30, 2017
Last Update Posted Date August 30, 2017
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8]) [ Time Frame: 0 to 8 hours post-dose ]
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
Time-weighted Sum of Pain Intensity Difference scores (SPID[11]) from 0-8 hours [ Time Frame: 0 to 8 hours ]
SPID [11] Time-weighted Sum of Pain Intensity Difference scores based on the 11-point Numerical Pain Severity Rating scale from 0 to 8 hours
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8]) [ Time Frame: 6 to 8 hours post-dose ]
    Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
  • Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose [ Time Frame: 0 to 8 hours, 6 to 8 hours post-dose ]
    TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
  • Time to Treatment Failure [ Time Frame: 0 to 12 hours post-dose ]
    Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.
  • Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours [ Time Frame: 6 hours, 8 hours post-dose ]
    Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.
  • Time to Onset of Meaningful Pain Relief [ Time Frame: 0 to 12 hours post-dose ]
    Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
  • SPID[11]6-8 [ Time Frame: 6 to 8 hours ]
    Time-weighted sum of PID[11] based on the 11-point Numerical Pain Severity Rating scale) from 6 to 8 hours
  • TOTPAR0-8 [ Time Frame: 0 to 8 hours ]
    Time weighted sum of pain relief rating scores from 0 to 8 hours
  • TOTPAR6-8 [ Time Frame: 6 to 8 hours ]
    Time weighted sum of pain relief rating scores over 6 to 8 hours
  • Duration of Relief [ Time Frame: 8 hours ]
    Measured by the time to treatment failure (i.e., time to first dose of rescue medication or drop out due to lack of efficacy)
  • Cumulative proportion of treatment failures [ Time Frame: 6, 8 hours ]
    Cumulative proportion of treatment failures at 6 and 8 hours
  • Time to onset of "meaningful" relief [ Time Frame: 8 hours ]
    Time to onset of "meaningful" relief
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2017)
  • Time to Confirmed Onset of First Perceptible Relief [ Time Frame: 0 to 12 hours post-dose ]
    Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
  • Pain Relief Rating (PRR) Score [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    Participants answered a question: "how much relief do you have from your starting pain?" on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.
  • Pain Intensity Difference on 11-Point Numerical Scale (PID11) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).
  • Pain Intensity Difference on 4-Point Categorical Scale (PID4) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).
  • Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
  • Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose [ Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose ]
    Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst) to 10 (best).
  • Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose [ Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose ]
    Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).
  • Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose [ Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose ]
    TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose [ Time Frame: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose ]
    SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.
  • Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.
  • Cumulative Percentage of Participants With Confirmed First Perceptible Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
  • Cumulative Percentage of Participants With Meaningful Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose ]
    Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
  • Participant's Global Evaluation of Study Medication [ Time Frame: 0 to 12 hours post-dose ]
    Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.
Original Other Pre-specified Outcome Measures
 (submitted: September 20, 2016)
  • Time to onset of "first perceptible" relief [ Time Frame: 8 hours ]
    Time to onset of "first perceptible" relief, confirmed by "meaningful" relief
  • Pain Relief Rating (PRR) [ Time Frame: 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose) ]
    Scored on the 5-point Categorical Pain Relief Rating Scale (0=No relief to 4=Complete relief) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose
  • Pain Intensity Difference (PID[11]) [ Time Frame: 0 to 12 hours ( at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose) ]
    Scored on the 11-point Numerical Pain Severity Rating Scale (0=None to 10=Worst Possible Pain) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8. 9, 10, 11, and 12 hours post-dose
  • Pain Intensity Difference (PID[4]) [ Time Frame: 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose) ]
    Scored on the 4-point Categorical Pain Severity Rating Scale (0=None to 3=Severe) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
  • Sum of pain relief rating and pain intensity difference scores (PRID[4]) [ Time Frame: 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose) ]
    Scored at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
  • Time weighted sum of PID[11] scores [ Time Frame: 12 hours (over 2 hours, 6 hours, and 12 hours post-dose) ]
    Scored over 2 hours (SPID[11]0 2), over 6 hours (SPID[11]0 6), and over 12 hours (SPID[11]0 12) post-dose
  • Time weighted sum of PID[4] scores [ Time Frame: 12 hours (over 2 hours, 6 hours, 8 hours and 12 hours post dose and over 6 to 8 hours post dose) ]
    Scored over 2 hours (SPID[4]0 2), over 6 hours (SPID[4]0 6), over 8 hours (SPID[4]0-8, over 12 hours (SPID[4]0 12), and over 6 to 8 hours (SPID[11]6-8) post-dose
  • Time weighted sum of pain relief rating scores [ Time Frame: 12 hours (over 2 hours, 6 hours and 12 hours post-dose) ]
    Scored over 2 hours (TOTPAR0 2), over 6 hours (TOTPAR0 6), and over 12 hours (TOTPAR0 12) post-dose
  • Time weighted sum of pain relief rating scores combined with PID[4] scores [ Time Frame: 12 hours ]
    Scored over 2 hours (SPRID[4]0 2), over 6 hours (SPRID[4]0 6), over 8 hours (SRPID[4]0-8), over 12 hours (SPRID[4]0 12), and over 6 to 8 hours (SPRID[4]6-8) post-dose
  • Cumulative proportion of treatment failures [ Time Frame: 12 hours ]
    Scored at 1.5, 2, 3, 4, 5, 7, 9, 10, 11, and 12 hours post dose
  • Cumulative proportion of subjects achieving "meaningful" and "first perceptible" relief (confirmed by "meaningful" relief) [ Time Frame: 12 hours ]
    Scored at 1.5, 2, 3, 4, 5, 7, 9, 10, 11, and 12 hours post dose
  • Subject global evaluation of study medication [ Time Frame: 12 hours ]
    Scored at 12 hours
 
Descriptive Information
Brief Title  ICMJE A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain
Official Title  ICMJE A Phase 3, Double-Blind, Randomized, Safety And Efficacy Study Comparing A Single Oral Dose Of Ibuprofen (IBU) 250 Mg/Acetaminophen (APAP) 500 Mg (Administered As Two Tablets Of IBU/APAP 125 Mg/250 Mg) To Each Active Drug Monocomponent Alone And To Placebo In The Treatment Of Post-Surgical Dental Pain
Brief Summary This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed.
Detailed Description This is a 12-hour, 4-arm, randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation (administered as two caplets of 125 mg/250 mg IBU/APAP) compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, otherwise healthy, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Upon completion of the baseline scales, eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. At 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose time points, subjects will provide: self-ratings of pain severity using the numerical and categorical PSRs; and self-ratings of pain relief at each time point using a categorical pain relief rating scale. At 12 hours, subjects will also complete a 6-point categorical Global Evaluation of the study medication. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method up to 12 hours post-dose or until the time of first rescue medication use, whichever is sooner. A review of any reported adverse events will also be completed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-surgical Pain Following Extraction of Molar Teeth
Intervention  ICMJE
  • Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
    2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg
    Other Name: IBU 250 / APAP 500
  • Drug: Ibuprofen 250 mg
    2 caplets of Ibuprofen 125 mg
    Other Name: IBU 250
  • Drug: Acetaminophen 650 mg
    2 tablets of Acetaminophen 325 mg
    Other Name: APAP 650
  • Drug: Placebo
    2 caplets of Placebo
Study Arms  ICMJE
  • Experimental: Ibuprofen 250 mg / Acetaminophen 500 mg
    2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg
    Intervention: Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
  • Active Comparator: Ibuprofen 250 mg
    2 caplets of IBU 125 mg
    Intervention: Drug: Ibuprofen 250 mg
  • Active Comparator: Acetaminophen 650 mg
    2 tablets of APAP 325 mg
    Intervention: Drug: Acetaminophen 650 mg
  • Active Comparator: Placebo
    2 caplets of Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2016)
568
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
  • Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
  • Female subjects are not pregnant or breast feeding.
  • Informed consent.

Exclusion Criteria:

  • Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
  • Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
  • Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02912650
Other Study ID Numbers  ICMJE B5061003
GEMINI SDDP ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP