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Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

NCT ID: NCT01098747

Last Updated: 2012-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Detailed Description

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Conditions

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Pain

Keywords

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Pain following third molar extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

Group Type EXPERIMENTAL

Novel Ibuprofen

Intervention Type DRUG

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

Treatment B

Group Type ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type DRUG

Single-dose of standard ibuprofen (400mg)

Treatment C

Group Type ACTIVE_COMPARATOR

Standard Ibuprofen

Intervention Type DRUG

Single-dose of standard ibuprofen (400mg)

Treatment D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single-dose of placebo

Interventions

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Novel Ibuprofen

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

Intervention Type DRUG

Standard Ibuprofen

Single-dose of standard ibuprofen (400mg)

Intervention Type DRUG

Standard Ibuprofen

Single-dose of standard ibuprofen (400mg)

Intervention Type DRUG

Placebo

Single-dose of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal, healthy males and females 16 to 40 years of age
* Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
* Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria

* Pregnancy or breast-feeding
* Alcohol or substance abuse
* Any serious medical or psychiatric disorder
* History of stomach ulcers, stomach bleed, or other bleeding disorders
* Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants\[including alcohol\])
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Countries

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United States

References

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Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

Reference Type DERIVED
PMID: 25526232 (View on PubMed)

Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142.

Reference Type DERIVED
PMID: 25119511 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=AH-09-10&StudyName=Study%20Evaluating%20A%20Novel%20Ibuprofen%20Formulation%20In%20The%20Treatment%20Of%20Dental%20Pain

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Other Identifiers

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AH-09-10

Identifier Type: -

Identifier Source: org_study_id