Last updated: 11/04/2018 04:21:41

Post-operative dental pain study comparing analgesic efficacy

GSK study ID
A4000684
See study documents
Clinicaltrials.gov ID
NCT01082081
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to compare the analgesic efficacy of two different paracetamol doses as measured by post-operative dental pain relief
Trial description: GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . 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 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Sum of Pain Relief and Pain Intensity Differences from 0 to 6 hours (SPRID 6 hours)

Timeframe: Every two hours from baseline to 6 hours post dose

Secondary outcomes:

Time to confirmed first perceptible pain relief

Timeframe: Baseline to 6 hours post dose

Time to onset of meaningful pain relief

Timeframe: Baseline to 6 hours post dose

Time to start using rescue medication

Timeframe: Baseline to 6 hours post dose

Percentage of participants who took rescue medication within 2 hours

Timeframe: Baseline to 2 hours post dose

Percentage of participants who took rescue medication during 2 to 6 hours

Timeframe: Within 2 to 6 hours post dose

SPRID at 2 hours

Timeframe: Every two hours from baseline to 2 hours post dose

SPRID at 4 hours

Timeframe: Every two hours from baseline to 4 hours post dose

Total Pain Relief (TOTPAR) at 2 hours

Timeframe: Every two hours from baseline to 2 hours post dose

TOTPAR at 4 hours

Timeframe: Every two hours from baseline to 4 hours post dose

TOTPAR at 6 hours

Timeframe: Every two hours from baseline to 6 hours post dose

Sum of Pain intensity difference (SPID) scores at 2 hours

Timeframe: Every two hours from baseline to 2 hours post dose

SPID scores at 4 hours

Timeframe: Every two hours from baseline to 4 hours post dose

SPID scores at 6 hours

Timeframe: Every two hours from baseline to 6 hours post dose

Participants Global Assessment to response to treatment (PGART)

Timeframe: Baseline to 6 hours post dose

Interventions:
  • Drug: Paracetamol 1000 mg
  • Drug: Paracetamol 500 mg
  • Drug: Placebo
    • Enrollment:
    300
    Primary completion date:
    2010-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Post-surgical dental pain
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to March 2010
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    PPD Dental Clinic
    Austin, TX, United States, 78744
    Status
    Recruiting
    Contact us
    Location
    Jean Brown Research
    Salt Lake City, UT, United States, 84124
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-03
    Actual study completion date
    2010-31-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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