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Trial record 1 of 1 for:    b5061004
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A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain

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ClinicalTrials.gov Identifier: NCT02837952
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.

Condition or disease Intervention/treatment Phase
Pain Drug: FDC IBU/APAP 250 mg/500 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-blind, Randomized Safety And Efficacy Study Comparing Multiple Administrations Of Ibu 250 Mg/Apap 500 Mg (Administered As Two Tablets Of Ibu/Apap 125 Mg/250 Mg) To Placebo In The Treatment Of Post Surgical Dental Pain In Adult Subjects
Actual Study Start Date : August 31, 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg
FDC IBU/APAP 250 mg/500 mg
Drug: FDC IBU/APAP 250 mg/500 mg
FDC IBU/APAP 250 mg/500 mg

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24]) [ Time Frame: 0 to 24 hours post dose ]
    Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 [0-24]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. 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).


Secondary Outcome Measures :
  1. Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose [ Time Frame: 0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose ]
    Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 [0-8]), -15 (worst score) to 30 (best score) for (SPID11 [6-8]), -80 (worst score) to 160 (best score) for (SPID11 [0-16]), -45 (worst score) to 90 (best score) for (SPID11 [8-16]), -240 (worst score) to 480 (best score) for (SPID11 [0-48]). 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).

  2. Duration of Relief After First Dose [ Time Frame: Up to 8 hours after first dose ]
    Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.

  3. Time to Onset of "Meaningful" Pain Relief After First Dose [ Time Frame: Up to 8 hours after first dose ]
    Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Males and females 18 years to 40 years of age (inclusive).
  2. 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.
  3. 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 (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
  4. In general good health and have no contraindications to the study or rescue medication.

Exclusion Criteria

  1. 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 of the following medical conditions/disorders:

    • Gastrointestinal ulcer or gastrointestinal bleeding;
    • Paralytic ileus or other gastrointestinal obstructive disorders;
    • Bleeding disorder.
  2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
  3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

    .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837952


Locations
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United States, Utah
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] February 9, 2017
Statistical Analysis Plan  [PDF] March 3, 2017


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02837952     History of Changes
Other Study ID Numbers: B5061004
GEMINI MDDP ( Other Identifier: Alias Study Number )
MDDP ( Other Identifier: Alias Study Number )
First Posted: July 20, 2016    Key Record Dates
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018
Last Verified: January 2018

Keywords provided by Pfizer:
Ibuprofen, acetaminophen, pain, molar extraction

Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics