Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01098747
Previous Study | Return to List | Next Study

Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

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: NCT01098747
Recruitment Status : Completed
First Posted : April 5, 2010
Results First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 5, 2010
Results First Submitted Date  ICMJE July 12, 2012
Results First Posted Date  ICMJE August 17, 2012
Last Update Posted Date August 17, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) [ Time Frame: 0 to 8 hours ]
    SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
  • Time to Onset of Meaningful Relief [ Time Frame: 0 to 8 hours ]
    Participants evaluated the 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 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
Time-weighted sum of pain relief & pain intensity difference scores over 8 hours & Time to onset of meaningful relief [ Time Frame: 0 to 8 hours ]
Change History Complete list of historical versions of study NCT01098747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Time to Confirmed First Perceptible Relief [ Time Frame: 0 to 8 hours ]
    Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
  • Pain Relief Rating (PRR) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
  • Pain Intensity Difference (PID) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).
  • Sum of Pain Relief Rating and Pain Intensity Difference (PRID) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
  • Time-weighted Sum of Pain Intensity Difference (SPID) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]
    SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).
  • Time-weighted Sum of Pain Relief Rating (TOTPAR) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]
    TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]
    SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).
  • Cumulative Percentage of Participants With Meaningful Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
  • 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 hours ]
    Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
  • Time to Treatment Failure [ Time Frame: 0 to 8 hours ]
    Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
  • Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
  • Cumulative Percentage of Participants With Complete Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]
    Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
  • Participant Global Evaluation of Study Medication [ Time Frame: 8 hours ]
    Participant global evaluation of study medication was performed at the 8-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 Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
Time to 1st perceptible relief(FPR); pain relief(PR), pain intensity difference(PID), sum of PR&PID;Time-weighted sum of PID, PR, & PID+PR; cumulative proportion meaningful & FPR,tx failure,complete relief;duration of relief;global eval [ Time Frame: 0 to 8 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Official Title  ICMJE Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I
Brief Summary This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Detailed Description Not Provided
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 Pain
Intervention  ICMJE
  • Drug: Novel Ibuprofen
    Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
  • Drug: Standard Ibuprofen
    Single-dose of standard ibuprofen (400mg)
  • Drug: Placebo
    Single-dose of placebo
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: Novel Ibuprofen
  • Active Comparator: Treatment B
    Intervention: Drug: Standard Ibuprofen
  • Active Comparator: Treatment C
    Intervention: Drug: Standard Ibuprofen
  • Placebo Comparator: Treatment D
    Intervention: Drug: Placebo
Publications *

*   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: April 1, 2010)
335
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal, healthy males and females 16 to 40 years of age
  • Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
  • Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Alcohol or substance abuse
  • Any serious medical or psychiatric disorder
  • History of stomach ulcers, stomach bleed, or other bleeding disorders
  • Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants[including alcohol])
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01098747
Other Study ID Numbers  ICMJE AH-09-10
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 2012

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