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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01098747
First received: April 1, 2010
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Novel Ibuprofen
Drug: Standard Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) [ Time Frame: 0 to 8 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Confirmed First Perceptible Relief [ Time Frame: 0 to 8 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 335
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Novel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
Active Comparator: Treatment B Drug: Standard Ibuprofen
Single-dose of standard ibuprofen (400mg)
Active Comparator: Treatment C Drug: Standard Ibuprofen
Single-dose of standard ibuprofen (400mg)
Placebo Comparator: Treatment D Drug: Placebo
Single-dose of placebo

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098747

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01098747     History of Changes
Other Study ID Numbers: AH-09-10
Study First Received: April 1, 2010
Results First Received: July 12, 2012
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pain following third molar extraction

Additional relevant MeSH terms:
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014