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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-31-03
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
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website