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

NCT00631111 | Completed Phase 3

• 1 other identifier: AI-07-02
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

dental pain; analgesic; NSAID; ibuprofen; aspirin

Outcome Measures

Primary Outcomes (1)

• Sum of pain relief and pain intensity difference scores

  8 hours

Secondary Outcomes (1)

• Time to meaningful pain relief

  8 hours

Study Arms (4)

1

EXPERIMENTAL

Drug: effervescent ibuprofen tablets

2

ACTIVE COMPARATOR

Drug: effervescent Aspirin plus Vitamin C tablets

3

ACTIVE COMPARATOR

Drug: ibuprofen tablets

4

PLACEBO COMPARATOR

Drug: placebo

Interventions

effervescent ibuprofen tablets DRUG

1

effervescent Aspirin plus Vitamin C tablets DRUG

2

ibuprofen tablets DRUG

3

placebo DRUG

4

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Pain; Toothache

Interventions

Ascorbic Acid; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Phenylpropionates; Acids, Carbocyclic

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 10, 2009

Record last verified: 2009-07

Locations

US (1)