Study Evaluating Ibuprofen 600 mg Extended Release (ER) F... | NCT00913627

NCT00913627

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
B4371001	Other Identifier	Alias Study Number

Status Module

Label	Type	Description	Intervention Names
1	Experimental	1 x 600 mg ibuprofen IR/ER-roller compaction caplet	Drug: ibuprofen
2	Experimental	1 x 600 mg ibuprofen IR/ER-Wet granulation caplet	Drug: ibuprofen
3	Active Comparator	1x 220 mg naproxen sodium (Aleve caplet)	Drug: naproxen
4	Placebo Comparator	1 x placebo caplet	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ibuprofen	Drug		1
ibuprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)	Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).	Baseline (0 hour) to 12 hours post dose
Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)	PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity).	8 to 12 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Time to First Perceptible Pain Relief	Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled "first perceptible relief", if the participant also depressed the second stopwatch labelled as "meaningful relief" by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

INCLUSION CRITERIA:

Males and females 16 to 40 years of age.
Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction;
Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam;
Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
Examined by the attending dentist or physician and medically cleared to participate in the study;
In general good health and have no contraindications to the study medication.

Exclusion Criteria:

EXCLUSION CRITERIA:

Pregnancy, as verified by a urine-based pregnancy test, or breast feeding;
Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, poorly-controlled hyper- or hypothyroidism);
Use of a prescription or nonprescription drug with which the administration of ibuprofen or any other NSAID is contraindicated;
Use of a bisphosphonate (e.g., risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years;
Acute localized dentalveolar infection at the time of surgery that could confound the post-surgical evaluation;
Females who are of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
History of alcoholism (i.e., on average, consumes 3 or more alcoholic drinks per day) or substance abuse within the last year, or is currently abusing alcohol or other mood-altering drugs (e.g., cannabis). Patients who are taking CNS or other psychotropic drugs (including St. John's Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;
Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week)
History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to ibuprofen, naproxen, aspirin, or to any other NSAID; or to codeine, hydrocodone, or acetaminophen, or to their combinations;
Prior use of any type of analgesic or NSAID five half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure;
Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less before taking the first dose of study medication;
The subject has taken an investigational product or participated in an investigational trial within 30 days of study enrollment;
The subject has previously participated in this study;
The subject is a member of the study site staff directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jean Brown Research Center		Salt Lake City	Utah	84124	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Placebo	Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
FG001	Ibuprofen IR/ER (Roller Compaction)	Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery
FG002	Ibuprofen IR/ER (Wet Granulation)	Ibuprofen 600 mg IR/ER-Wet Granulation (IR/ER-WG): one 600 mg active caplet on day of surgery
FG003	Naproxen	Naproxen 220 mg (Aleve) caplet: one 220 mg active caplet on day of surgery

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery
BG001	Ibuprofen IR/ER (Roller Compaction)	Ibuprofen 600 milligram (mg) IR/ER-roller compaction (IR/ER-RC): one 600 mg active caplet on day of surgery

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)

Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity).

Intent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment.

Posted

Mean

Standard Deviation

units on a scale

Baseline (0 hour) to 12 hours post dose

ID	Title	Description
OG000	Placebo	Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching placebo immediate release/extended release (IE/ER) caplet on day of surgery

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals