Post-operative Dental Pain Study Comparing Analgesic Efficacy

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

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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