A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain
NCT02912650
Last updated date
ABOUT THIS STUDY
This is a randomized, double blind, placebo-controlled, parallel group, single-center study
in approximately 560 subjects to determine the overall analgesic efficacy and safety of a
fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg
alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females
aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical
extraction of 3 or more third molar teeth. Following extraction, subjects must experience,
within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical
scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm
on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose
of study medication under double-blind conditions and then evaluated on site for 12 hours
following administration of study medication. Subjects will provide self-ratings of pain
severity and pain relief at various time points using categorical and numerical scales.
Additionally, subjects will also evaluate the time to first perceptible relief and time to
meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will
complete a categorical Global Evaluation of the study medication. A review of any reported
adverse events will also be completed.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-surgical Pain Following Extraction of Molar Teeth
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
- Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
- Female subjects are not pregnant or breast feeding.
- Informed consent.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
disorder determined by the Investigator to place the subject at increased risk,
including the presence or history within 2 years of screening.
- Acute localized dental alveolar infection at the time of surgery that could confound
the post-surgical evaluation.
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
tramadol, other opioids, or to their combinations.
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Post-surgical Pain Following Extraction of Molar TeethA Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain
NCT02912650
- Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain | |||
| Official Title ICMJE | A Phase 3, Double-Blind, Randomized, Safety And Efficacy Study Comparing A Single Oral Dose Of Ibuprofen (IBU) 250 Mg/Acetaminophen (APAP) 500 Mg (Administered As Two Tablets Of IBU/APAP 125 Mg/250 Mg) To Each Active Drug Monocomponent Alone And To Placebo In The Treatment Of Post-Surgical Dental Pain | |||
| Brief Summary | This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed. | |||
| Detailed Description | This is a 12-hour, 4-arm, randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation (administered as two caplets of 125 mg/250 mg IBU/APAP) compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, otherwise healthy, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Upon completion of the baseline scales, eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. At 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose time points, subjects will provide: self-ratings of pain severity using the numerical and categorical PSRs; and self-ratings of pain relief at each time point using a categorical pain relief rating scale. At 12 hours, subjects will also complete a 6-point categorical Global Evaluation of the study medication. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method up to 12 hours post-dose or until the time of first rescue medication use, whichever is sooner. A review of any reported adverse events will also be completed. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Post-surgical Pain Following Extraction of Molar Teeth | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 568 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | June 2016 | |||
| Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 40 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02912650 | |||
| Other Study ID Numbers ICMJE | B5061003 GEMINI SDDP ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||