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| ID | Type | Description | Link |
|---|---|---|---|
| GEMINI MDDP | Other Identifier | Alias Study Number | |
| MDDP | Other Identifier | Alias Study Number |
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This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg | Active Comparator | FDC IBU/APAP 250 mg/500 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC IBU/APAP 250 mg/500 mg | Drug | FDC IBU/APAP 250 mg/500 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24]) | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 [0-24]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). | 0 to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 [0-8]), -15 (worst score) to 30 (best score) for (SPID11 [6-8]), -80 (worst score) to 160 (best score) for (SPID11 [0-16]), -45 (worst score) to 90 (best score) for (SPID11 [8-16]), -240 (worst score) to 480 (best score) for (SPID11 [0-48]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). |
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Inclusion Criteria
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 of the following medical conditions/disorders:
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.
.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc. | Salt Lake City | Utah | 84106 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
| FG001 | Ibuprofen 250 mg / Acetaminophen 500 mg | Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24]) | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 [0-24]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). | The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a Scale | 0 to 24 hours post dose |
|
Baseline up to 28 days after the last dose (up to 30 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA v19.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2017 | Jan 31, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2017 | Jan 31, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Placebo |
|
| 0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose |
| Duration of Relief After First Dose | Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation. | Up to 8 hours after first dose |
| Time to Onset of "Meaningful" Pain Relief After First Dose | Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first. | Up to 8 hours after first dose |
| Medication Error |
|
| BG001 | Ibuprofen 250 mg / Acetaminophen 500 mg | Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Placebo |
Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
| OG001 | Ibuprofen 250 mg / Acetaminophen 500 | Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). |
|
|
|
| Secondary | Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose | Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 [0-8]), -15 (worst score) to 30 (best score) for (SPID11 [6-8]), -80 (worst score) to 160 (best score) for (SPID11 [0-16]), -45 (worst score) to 90 (best score) for (SPID11 [8-16]), -240 (worst score) to 480 (best score) for (SPID11 [0-48]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). | The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | 0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose |
|
|
|
|
| Secondary | Duration of Relief After First Dose | Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation. | The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | Up to 8 hours after first dose |
|
|
|
|
| Secondary | Time to Onset of "Meaningful" Pain Relief After First Dose | Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first. | The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. | Posted | Median | 95% Confidence Interval | minutes | Up to 8 hours after first dose |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 14 |
| 41 |
| EG001 | Ibuprofen 250 mg / Acetaminophen 500 mg | Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30). | 0 | 82 | 0 | 82 | 11 | 82 |
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v19.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v19.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v19.1 | Non-systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v19.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA v19.1 | Non-systematic Assessment |
|
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.
| 0 to 16 hours |
|
| 8 to 16 hours |
|
| 0 to 48 hours |
|
6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate. |
| ANCOVA |
| < 0.001 |
| LS Mean Difference |
| 7.91 |
| 2-Sided |
| 95 |
| 5.196 |
| 10.632 |
| Superiority |
| 0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate. | ANCOVA | < 0.001 | LS Mean Difference | 51.67 | 2-Sided | 95 | 37.075 | 66.258 | Superiority |
| 8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate. | ANCOVA | < 0.001 | LS Mean Difference | 27.32 | 2-Sided | 95 | 18.139 | 36.508 | Superiority |
| 0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate. | ANCOVA | < 0.001 | LS Mean Difference | 138.65 | 2-Sided | 95 | 91.045 | 186.261 | Superiority |