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Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00631111
Enrollment
270
Registered
2008-03-07
Start date
2007-11-30
Completion date
2008-04-30
Last updated
2009-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

dental pain, analgesic, NSAID, ibuprofen, aspirin

Brief summary

Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.

Interventions

DRUGeffervescent ibuprofen tablets
DRUGeffervescent Aspirin plus Vitamin C tablets
DRUGplacebo

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: * Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone) * Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide Exclusion: * Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function) * Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation * Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Design outcomes

Primary

MeasureTime frame
Sum of pain relief and pain intensity difference scores8 hours

Secondary

MeasureTime frame
Time to meaningful pain relief8 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026