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A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

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ClinicalTrials.gov Identifier: NCT02863575
Recruitment Status : Completed
First Posted : August 11, 2016
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE August 11, 2016
Results First Submitted Date  ICMJE February 28, 2019
Results First Posted Date  ICMJE April 8, 2019
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE October 24, 2017
Actual Primary Completion Date April 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen [ Time Frame: From 0 to 8 hours post-dose on Day 1 ]
SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
SPRID0-8 [ Time Frame: 0-8 hours ]
Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) from 0 to 8 hours
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) [ Time Frame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 ]
    SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain.
  • Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) [ Time Frame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 ]
    SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain.
  • Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) [ Time Frame: From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 ]
    TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain.
  • Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1 ]
    PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain.
  • Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 ]
    PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain.
  • Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 ]
    NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain.
  • Time to Onset of Achieving Meaningful Relief [ Time Frame: Up to 8 hours post-dose on Day 1 ]
    When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "meaningful relief" at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered).
  • Time to Onset of First Perceptible Relief [ Time Frame: Up to 8 hours post-dose on Day 1 ]
    When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "first perceptible relief" at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered).
  • Time to Treatment Failure [ Time Frame: Up to 8 hours post dose on Day 1 ]
    Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
  • SPRID [ Time Frame: 0-8 hours ]
    Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) scores over 2 hours (SPRID0-2), over 4 hours (SPRID0-4), over 6 hours (SPRID0-6) and over 8 hours (SPRID0-8, for IBU 400 mg with caffeine 100 mg versus placebo comparison) post dose
  • SPID [ Time Frame: 0-8 hours ]
    Time-weighted sum of pain intensity difference (PID) scores over 2 hours (SPID0-2), over 4 hours (SPID0-4), over 6 hours (SPID0-6), and over 8 hours (SPID0-8) post dose
  • TOTPAR [ Time Frame: 0-8 hours ]
    Time-weighted sum of pain relief rating (PRR) over 2 hours (TOTPAR0-2), over 4 hours (TOTPAR0-4), over 6 hours (TOTPAR0-6), and over 8 hours (TOTPAR0-8) post dose
  • PRID [ Time Frame: 0-8 hours ]
    The sum of pain relief rating and pain intensity difference scores (PRID) at 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post dose
  • PRR [ Time Frame: 0-8 hours ]
    Pain Relief Rating (PRR): 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, and 8 hours post dose
  • PID [ Time Frame: 0-8 hours ]
    Pain Intensity Difference (PID): calculated as the baseline 11-point Numerical Pain Severity Rating (NPSR) minus the post-dose NPSR at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post dose
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2019)
  • Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity [ Time Frame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs are classified according to severity in 3 categories as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).
  • Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs) [ Time Frame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) ]
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. Relatedness of an AE to study drug was assessed by investigator.
  • Number of Participants With Clinically Significant Vital Signs Abnormalities [ Time Frame: Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days) ]
    Vital signs included: heart rate, blood pressure, respiratory rate, and temperature. Normal range for the vital signs were: systolic blood pressure 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure 60 to 90 mmHg, heart rate 50 to 110 beats per minute, respiratory rate 12 to 22 breaths per minute, and oral temperature 97.0 to 99.6 Fahrenheit (F). Value for vital signs outside the normal range was consider as abnormal. Clinical significance of vital signs abnormalities was determined at the investigator's discretion.
  • Number of Participants Who Used Concomitant Medications, and Rescue Medications [ Time Frame: Day 1 ]
    Rescue medication: participants who did not experience adequate relief after the 1 hour (post study drug dose) evaluation were given tramadol hydrochloride 50 to 100 mg orally or codeine sulfate 15 to 60 mg orally, based on the discretion of the Investigator, as rescue medication. If needed, 2 additional doses of rescue medications based on the discretion of the Investigator at the study center was given. Total maximum dose of tramadol was 300 mg and of codeine sulfate was 180 mg. Concomitant medication: medication received by participant other than study medication and rescue medication.
  • Number of Participants Who Used Medications Prior to This Study [ Time Frame: At Screening ]
    In this outcome measure number of participants who were using any type of medications, prior to start of the study were reported.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS
Brief Summary An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
Detailed Description The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ibuprofen/Caffeine
    Ibuprofen/Caffeine fixed-dose combination
  • Drug: Ibuprofen
    Ibuprofen capsule
  • Drug: Placebo
    Placebo treatment
Study Arms  ICMJE
  • Experimental: Ibuprofen/Caffeine
    Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination
    Intervention: Drug: Ibuprofen/Caffeine
  • Active Comparator: Ibuprofen
    Ibuprofen 400 mg
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Placebo comparator
    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: May 15, 2018)
374
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
385
Actual Study Completion Date  ICMJE April 6, 2018
Actual Primary Completion Date April 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females 16 years to 40 years of age (inclusive).
  • Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
  • Examined by the attending dentist or physician and medically cleared to participate in the study.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) 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:

    • Bleeding disorder;
    • Gastrointestinal ulcer or gastrointestinal bleeding;
    • Paralytic ileus or other gastrointestinal obstructive disorders.
  • Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
  • Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02863575
Other Study ID Numbers  ICMJE B3741002
MIG ( Other Identifier: Alias Study Number )
MIG II ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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 April 2019

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