Post-operative Dental Pain Study Comparing Analgesic Efficacy - Full Text View

Purpose

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).

Condition	Intervention	Phase
Post-surgical Dental Pain	Drug: Paracetamol 1000 mg Drug: Paracetamol 500 mg Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief

Resource links provided by NLM:

Drug Information available for: Acetaminophen

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Sum of Pain Relief and Pain Intensity Differences from 0 to 6 hours (SPRID 6 hours) [ Time Frame: Baseline to 6 hours post dose ] [ Designated as safety issue: No ]
SPRID: sum of pain intensity difference (PID) and total pain relief (TOTPAR) at each post-dosing time point. PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [no pain] to 100 [worst possible pain]) from the baseline score. TOTPAR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).

Secondary Outcome Measures:

Time to confirmed first perceptible pain relief [ Time Frame: Baseline to 6 hours post dose ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Participants evaluated 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 ] [ Designated as safety issue: No ]
Median time of use of rescue medication by participants.
Proportion of participants with confirmed first perceptible relief [ Time Frame: 1 hour, 2 hours post-dose ] [ Designated as safety issue: No ]
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.
Proportion of participants with meaningful pain relief [ Time Frame: Baseline to 6 hours post dose ] [ Designated as safety issue: No ]
Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
Proportion of participants who took rescue medication [ Time Frame: 2 hours, 6 hours post dose ] [ Designated as safety issue: No ]
Percentage of participants who received rescue medication at different time points post dose.
SPRID at 2 hours and 4 hours [ Time Frame: Baseline, 2 hours, 4 hours post dose ] [ Designated as safety issue: No ]
SPRID: Time weighted sum of PRID over 2 hours and 4 hours. PRID: sum of PID and TOTPAR at each post-dosing time point. PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [no pain] to 100 [worst possible pain]) from the baseline score. TOTPAR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Total pain relief score (TOTPAR) [ Time Frame: Baseline, 2 hours, 4 hours, 6 hours post dose ] [ Designated as safety issue: No ]
TOTPAR: time-weighted sum of pain relief over 2, 4, and 6 hours. Pain relief was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). TOTPAR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Sum of Pain intensity difference (SPID) scores [ Time Frame: Baseline, 2 hours, 4 hours, 6 hours post dose ] [ Designated as safety issue: No ]
SPID: time-weighted sum of PID over 2, 4 and 6 hours. PID was derived by subtracting the pain severity score at a given post-dosing time point from the baseline score. Pain severity score ranged from 0 - no pain to 100 -worst possible pain.
Participants Global Assessment to response to treatment (PGART) [ Time Frame: Baseline to 6 hours post dose ] [ Designated as safety issue: No ]
PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.

Enrollment:	350
Study Start Date:	October 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Paracetamol 1000 mg Paracetamol 1000 mg	Drug: Paracetamol 1000 mg Paracetamol 1000 mg
Experimental: Paracetamol 500 mg Paracetamol 500 mg	Drug: Paracetamol 500 mg Paracetamol 500 mg
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082081

Locations

United States, Texas
PPD Dental Clinic
Austin, Texas, United States, 78744
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01082081 History of Changes
Other Study ID Numbers:	A4000684
Study First Received:	February 18, 2010
Last Updated:	January 24, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:

paracetamol
Post-surgical dental pain
dental pain

Additional relevant MeSH terms:

Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Acetaminophen
Analgesics

Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013