Post-surgical Pain Following Extraction of Molar Teeth Clinical Trial
— SDDPOfficial title:
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
| Verified date | September 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 568 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - 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: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Jean Brown Research | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time to onset of "first perceptible" relief | Time to onset of "first perceptible" relief, confirmed by "meaningful" relief | 8 hours | No |
| Other | Pain Relief Rating (PRR) | Scored on the 5-point Categorical Pain Relief Rating Scale (0=No relief to 4=Complete relief) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose | 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose) | No |
| Other | Pain Intensity Difference (PID[11]) | Scored on the 11-point Numerical Pain Severity Rating Scale (0=None to 10=Worst Possible Pain) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8. 9, 10, 11, and 12 hours post-dose | 0 to 12 hours ( at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post-dose) | No |
| Other | Pain Intensity Difference (PID[4]) | Scored on the 4-point Categorical Pain Severity Rating Scale (0=None to 3=Severe) at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose | 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose) | No |
| Other | Sum of pain relief rating and pain intensity difference scores (PRID[4]) | Scored at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose | 0 to 12 hours (at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose) | No |
| Other | Time weighted sum of PID[11] scores | Scored over 2 hours (SPID[11]0 2), over 6 hours (SPID[11]0 6), and over 12 hours (SPID[11]0 12) post-dose | 12 hours (over 2 hours, 6 hours, and 12 hours post-dose) | No |
| Other | Time weighted sum of PID[4] scores | Scored over 2 hours (SPID[4]0 2), over 6 hours (SPID[4]0 6), over 8 hours (SPID[4]0-8, over 12 hours (SPID[4]0 12), and over 6 to 8 hours (SPID[11]6-8) post-dose | 12 hours (over 2 hours, 6 hours, 8 hours and 12 hours post dose and over 6 to 8 hours post dose) | No |
| Other | Time weighted sum of pain relief rating scores | Scored over 2 hours (TOTPAR0 2), over 6 hours (TOTPAR0 6), and over 12 hours (TOTPAR0 12) post-dose | 12 hours (over 2 hours, 6 hours and 12 hours post-dose) | No |
| Other | Time weighted sum of pain relief rating scores combined with PID[4] scores | Scored over 2 hours (SPRID[4]0 2), over 6 hours (SPRID[4]0 6), over 8 hours (SRPID[4]0-8), over 12 hours (SPRID[4]0 12), and over 6 to 8 hours (SPRID[4]6-8) post-dose | 12 hours | No |
| Other | Cumulative proportion of treatment failures | Scored at 1.5, 2, 3, 4, 5, 7, 9, 10, 11, and 12 hours post dose | 12 hours | No |
| Other | Cumulative proportion of subjects achieving "meaningful" and "first perceptible" relief (confirmed by "meaningful" relief) | Scored at 1.5, 2, 3, 4, 5, 7, 9, 10, 11, and 12 hours post dose | 12 hours | No |
| Other | Subject global evaluation of study medication | Scored at 12 hours | 12 hours | No |
| Primary | Time-weighted Sum of Pain Intensity Difference scores (SPID[11]) from 0-8 hours | SPID [11] Time-weighted Sum of Pain Intensity Difference scores based on the 11-point Numerical Pain Severity Rating scale from 0 to 8 hours | 0 to 8 hours | No |
| Secondary | SPID[11]6-8 | Time-weighted sum of PID[11] based on the 11-point Numerical Pain Severity Rating scale) from 6 to 8 hours | 6 to 8 hours | No |
| Secondary | TOTPAR0-8 | Time weighted sum of pain relief rating scores from 0 to 8 hours | 0 to 8 hours | No |
| Secondary | TOTPAR6-8 | Time weighted sum of pain relief rating scores over 6 to 8 hours | 6 to 8 hours | No |
| Secondary | Duration of Relief | Measured by the time to treatment failure (i.e., time to first dose of rescue medication or drop out due to lack of efficacy) | 8 hours | No |
| Secondary | Cumulative proportion of treatment failures | Cumulative proportion of treatment failures at 6 and 8 hours | 6, 8 hours | No |
| Secondary | Time to onset of "meaningful" relief | Time to onset of "meaningful" relief | 8 hours | No |