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

NCT ID: NCT00631111

Last Updated: 2009-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

effervescent ibuprofen tablets

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

effervescent Aspirin plus Vitamin C tablets

Intervention Type DRUG

3

Group Type ACTIVE_COMPARATOR

ibuprofen tablets

Intervention Type DRUG

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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effervescent ibuprofen tablets

Intervention Type DRUG

effervescent Aspirin plus Vitamin C tablets

Intervention Type DRUG

ibuprofen tablets

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AI-07-02

Identifier Type: -

Identifier Source: org_study_id

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