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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Post-surgical Dental Pain

Treatments: Drug: Paracetamol 1000 mg; Drug: Placebo; Drug: Paracetamol 650 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01075243

A4000685

Details and patient eligibility

About

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).

Enrollment: 401 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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401 participants in 3 patient groups, including a placebo group

Paracetamol 1000mg

Experimental group

Description:

Paracetamol 1000mg

Treatment:

Drug: Paracetamol 1000 mg

Paracetamol 650 mg

Experimental group

Description:

Paracetamol 650 mg

Treatment:

Drug: Paracetamol 650 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo