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

Pain Clinical Trial

Official title:

Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631111
• Other study ID #: AI-07-02
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2008
• Last updated: July 10, 2009
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Toothache

Intervention

Drug:
• effervescent ibuprofen tablets

• effervescent Aspirin plus Vitamin C tablets

• ibuprofen tablets

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain relief and pain intensity difference scores		8 hours	No
Secondary	Time to meaningful pain relief		8 hours	No