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Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

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ClinicalTrials.gov Identifier: NCT01075243
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 23, 2010
First Posted Date  ICMJE February 25, 2010
Results First Submitted Date  ICMJE June 20, 2013
Results First Posted Date  ICMJE April 29, 2015
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) [ Time Frame: Every two hours from Baseline to 6 hours post dose ]
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
Change from baseline in the Sum of Pain Relief and Pain Intensity Differences (SPRID) at 6 hours [ Time Frame: Baseline to 6 horus post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • Time to Confirmed First Perceptible Relief [ Time Frame: Baseline to 6 hours post dose ]
    Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
  • Time to Onset of Meaningful Pain Relief [ Time Frame: Baseline to 6 hours post dose ]
    Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
  • Time to Start Using Rescue Medication [ Time Frame: Baseline to 6 hours post dose ]
    Median time of use of rescue medication by participants.
  • Percentage of Participants Who Took Rescue Medication at 2 Hours [ Time Frame: Baseline to 2 hours post dose ]
    Percentage of participants who received rescue medication at different time points post dose.
  • Percentage of Participants Who Took Rescue Medication at 6 Hours [ Time Frame: Baseline to 6 hours post dose ]
    Percentage of participants who received rescue medication at different time points post dose.
  • SPRID at 2 Hours [ Time Frame: Every two hours from baseline to 2 hours post dose ]
    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief
  • SPRID at 4 Hours [ Time Frame: Every two hours from baseline to 4 hours post dose ]
    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief
  • Total Pain Relief Score (TOTPAR) at 2 Hours [ Time Frame: Every two hours from baseline to 2 hours post dose ]
    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
  • TOTPAR at 4 Hours [ Time Frame: Every two hours from baseline to 4 hours post dose ]
    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
  • TOTPAR at 6 Hours [ Time Frame: Every two hours from baseline to 6 hours post dose ]
    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].
  • Sum of Pain Intensity Difference (SPID) Scores at 2 Hours [ Time Frame: Every two hours from baseline to 2 hours post dose ]
    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
  • SPID Scores at 4 Hours [ Time Frame: Every two hours from baseline to 4 hours post dose ]
    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
  • SPID Scores at 6 Hours [ Time Frame: Every two hours from baseline to 6 hours post dose ]
    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
  • Participants Global Assessment to Response to Treatment (PGART) [ Time Frame: Baseline to 6 hours post dose ]
    PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
  • Time to meaningful relief [ Time Frame: Baseline to 6 hours post dose ]
  • Proportion of subjects in the paracetamol groups with first perceptible relief confirmed within 1 hour post dose [ Time Frame: 1 hour post dose ]
  • Proportion of subjects in the paracetamol groups with first perceptible relief confirmed within 2 hours post dose [ Time Frame: 2 hours post dose ]
  • Proportion of subjects in the paracetamol groups with meaningful relief at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Change from baseline in SPRID (Sum of Pain Relief and Pain Intensity Differences) at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Change from baseline in Total Pain Relief Score (TOTPAR) at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Time to perceptible relief [ Time Frame: Baseline to 6 hours post dose ]
  • Change from baseline Sum of Pain Intensity Differences (SPID) at individual time points [ Time Frame: Baseline to 6 hours post dose ]
  • Time to rescue analgesic [ Time Frame: Baseline to 6 hours post dose ]
  • Proportion of subjects taking rescue medication at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Pain relief measured by a Verbal Categorized Scale at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Pain intensity difference (PID) scores at individual time points post dose [ Time Frame: Baseline to 6 hours post dose ]
  • Global evaluation of treatment experience based on a categorical scale at 6 hours post dose [ Time Frame: 6 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
Official Title  ICMJE A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Pain Relief
Brief Summary GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-surgical Dental Pain
Intervention  ICMJE
  • Drug: Paracetamol 1000 mg
    Paracetamol 1000mg
  • Drug: Paracetamol 650 mg
    Paracetamol 650 mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Paracetamol 1000mg
    Paracetamol 1000mg
    Intervention: Drug: Paracetamol 1000 mg
  • Experimental: Paracetamol 650 mg
    Paracetamol 650 mg
    Intervention: Drug: Paracetamol 650 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.

*   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 27, 2015)
401
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
440
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level.

Exclusion Criteria:

  • Pregnant and lactating females
  • Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
  • Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT01075243
Other Study ID Numbers  ICMJE A4000685
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2015

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