Post-operative Dental Pain Study Comparing Analgesic Efficacy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Post-surgical Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Paracetamol 1000 mg

Group Type EXPERIMENTAL

Paracetamol 1000 mg

Intervention Type DRUG

Paracetamol 1000 mg

Paracetamol 500 mg

Group Type EXPERIMENTAL

Paracetamol 500 mg

Intervention Type DRUG

Paracetamol 500 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Paracetamol 1000 mg

Intervention Type DRUG

Paracetamol 500 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No