Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. 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 18 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 1000mg

Group Type EXPERIMENTAL

Paracetamol 1000 mg

Intervention Type DRUG

Paracetamol 1000mg

Paracetamol 650 mg

Group Type EXPERIMENTAL

Paracetamol 650 mg

Intervention Type DRUG

Paracetamol 650 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Paracetamol 1000 mg

Paracetamol 1000mg

Intervention Type DRUG

Paracetamol 650 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level.

Exclusion Criteria

* Pregnant and lactating females
* Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
* Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No