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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01098747

First received: April 1, 2010

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Results First Received: July 12, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Pain
Interventions:	Drug: Novel Ibuprofen Drug: Standard Ibuprofen Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Single oral dose of 2 placebo tablets.
Ibuprofen Sodium	Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
Ibuprofen (Advil)	Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
Ibuprofen (Motrin IB)	Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Participant Flow: Overall Study

	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)
STARTED	48	95	86	87
COMPLETED	48	95	86	87
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Single oral dose of 2 placebo tablets.
Ibuprofen Sodium	Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
Ibuprofen (Advil)	Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
Ibuprofen (Motrin IB)	Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
Total	Total of all reporting groups

Baseline Measures

	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)	Total
Number of Participants [units: participants]	48	95	86	87	316
Age [units: Years] Mean ± Standard Deviation	18.1 ± 1.6	18.6 ± 2.1	18.6 ± 2.3	18.4 ± 2.0	18.5 ± 2.1
Gender [units: Participants]
Female	25	48	44	44	161
Male	23	47	42	43	155
Number of Participants with Pain Severity Score ^[1] [units: Participants]
Moderate	27	51	43	43	164
Severe	21	44	43	44	152

[1]	Pain severity score was assessed on a 4-point categorical scale. Total possible pain severity score range was 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Outcome Measures

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1. Primary:

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) [ Time Frame: 0 to 8 hours ]

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2. Primary:

Time to Onset of Meaningful Relief [ Time Frame: 0 to 8 hours ]

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3. Secondary:

Time to Confirmed First Perceptible Relief [ Time Frame: 0 to 8 hours ]

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4. Secondary:

Pain Relief Rating (PRR) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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5. Secondary:

Pain Intensity Difference (PID) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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6. Secondary:

Sum of Pain Relief Rating and Pain Intensity Difference (PRID) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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7. Secondary:

Time-weighted Sum of Pain Intensity Difference (SPID) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]

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8. Secondary:

Time-weighted Sum of Pain Relief Rating (TOTPAR) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]

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9. Secondary:

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) [ Time Frame: 0-2, 0-3, 0-6, 0-8 hours ]

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10. Secondary:

Cumulative Percentage of Participants With Meaningful Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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11. Secondary:

Cumulative Percentage of Participants With Confirmed First Perceptible Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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12. Secondary:

Time to Treatment Failure [ Time Frame: 0 to 8 hours ]

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13. Secondary:

Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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14. Secondary:

Cumulative Percentage of Participants With Complete Relief [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours ]

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15. Secondary:

Participant Global Evaluation of Study Medication [ Time Frame: 8 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01098747 History of Changes
Other Study ID Numbers:	AH-09-10
Study First Received:	April 1, 2010
Results First Received:	July 12, 2012
Last Updated:	July 12, 2012
Health Authority:	United States: Food and Drug Administration

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