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Post-operative Dental Pain Study Comparing Analgesic Efficacy

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 4

Conditions

Post-surgical Dental Pain

Treatments

Drug: Paracetamol 500 mg
Drug: Paracetamol 1000 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01082081
A4000684

Details and patient eligibility

About

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).

Enrollment

300 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 3 patient groups, including a placebo group

Paracetamol 1000 mg
Experimental group
Description:
Paracetamol 1000 mg
Treatment:
Drug: Paracetamol 1000 mg
Paracetamol 500 mg
Experimental group
Description:
Paracetamol 500 mg
Treatment:
Drug: Paracetamol 500 mg
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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