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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-005031-17 | EudraCT Number |
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The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen Sodium : Acetaminophen | Experimental | Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2 |
|
| Acetaminophen : Naproxen Sodium | Experimental | Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium, (Aleve, BAY117031) | Drug | 220 mg *2 tablets, orally, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief. | Up to 12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference (SPID) Over 0-12 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115. |
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Inclusion Criteria:
Ambulatory healthy female patients between 15 and 35 years of age;
Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
Patient has a self-reported history of primary dysmenorrhea (onset <5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles;
Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded;
Patient typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, acetaminophen, or ibuprofen taken on at least 1 day of her menstrual cycle for the treatment of moderate or severe menstrual cramp, and normally experiences pain relief from these medications;
Patient is of child-bearing potential and is using one of the following methods of contraception and agrees to continue this same method for the duration of the study:
Patient is willing to participate in the study and return to the study site within approximately 1 week after her menstrual cycle to return the study medication, urine pregnancy test, and for review of the completed patient e-diary;
Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period;
Patient is willing to abstain from caffeine consumption throughout the 12-hour Treatment Period;
Patient is willing to ingest the overencapsulated tablets throughout the study;
Patient is willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other study procedures according to the clinical protocol.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Chandler | Arizona | 85224 | United States | ||
| Radiant Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31397597 | Derived | Daniels SE, Paredes-Diaz A, An R, Centofanti R, Tajaddini A. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019 Dec;35(12):2139-2147. doi: 10.1080/03007995.2019.1654987. Epub 2019 Aug 28. |
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Overall, 242 participants were screened. Of them, 201 participants were randomized, and 196 received study treatment.
Study was conducted at multiple centers in the US between 05 April 2018 (first patient first visit) and 05 September 2018 (last patient last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Sodium : Acetaminophen | Participants received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2 |
| FG001 | Acetaminophen : Naproxen Sodium | Participants received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population (included all randomized participants who took at least one dose of investigational medicinal product [IMP])
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Sodium : Acetaminophen | Participants received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2 |
| BG001 | Acetaminophen : Naproxen Sodium |
| 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 | Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief. | PP population per treatment received (included all participants who were randomized and provided at least one measure of an efficacy parameter after the first dose of investigational medicinal product [IMP] without any major protocol violations) | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | Up to 12 hours post-dose |
|
The observation phase for adverse events (AEs) started with signing the informed consent form and ended in general with the last visit of follow-up (up to 133 days). After the end of follow-up there was no requirement to actively collect AEs.
In case of ongoing AEs after the last follow-up visit - especially when related to treatment with the study medication - the respective AE was followed until resolution, if possible.
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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 | Naproxen Sodium | Participants received one single oral dose of 440 mg naproxen sodium (safety population per treatment received) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+) 1-888-8422937 | clinical-trials-contact@bayer.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 | Apr 16, 2018 | Aug 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2018 | Aug 14, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Acetaminophen (Tylenol Extra Strength) | Drug | 500 mg *2 caplets, orally, single dose |
|
| Up to 12 hours post-dose |
| SPID Over 0-6 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55. | Up to 6 hours post-dose |
| SPID Over 6-12 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60. | From 6 hours to 12 hours post-dose |
| TOTPAR Over 0-6 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief. | Up to 6 hours post-dose |
| TOTPAR 6-12 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief. | From 6 hours to 12 hours post-dose |
| Time to First Intake of Rescue Medication | Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment. | Up to 12 hours post-dose |
| Pain Intensity Difference (PID) Scores at Each Evaluation | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. | Up to 12 hours post-dose |
| Number of Participants by Global Evaluation Scores | Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.' | Up to 12 hours post-dose |
| Pain Relief Scores at Each Evaluation | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). | Up to 12 hours post-dose |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| Radiant Research, Inc. | Chicago | Illinois | 60602 | United States |
| Radiant Research, Inc. | Akron | Ohio | 44311 | United States |
| Radiant Research, Inc. | Cincinnati | Ohio | 45236 | United States |
| Radiant Research, Inc. | Dallas | Texas | 75234 | United States |
| Synexus US, LP- Plano | Plano | Texas | 75234 | United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Inadequate pain reporter |
|
| Other |
|
| Physician Decision |
|
Participants received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| At least moderate pain intensity during 4 of last 6 menstrual cycles | Pain intensity was measured using Categorical Pain Intensity (0 = none, 1 = mild, 2 = moderate, 3 = severe). | Count of Participants | Participants |
|
Participants received one single oral dose of 440 mg naproxen sodium
| OG001 | Acetaminophen | Participants received one single oral dose of 1000 mg acetaminophen |
|
|
|
| Secondary | Summed Pain Intensity Difference (SPID) Over 0-12 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115. | PP population per treatment received | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | Up to 12 hours post-dose |
|
|
|
|
| Secondary | SPID Over 0-6 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55. | PP population per treatment received | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | Up to 6 hours post-dose |
|
|
|
|
| Secondary | SPID Over 6-12 Hours | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60. | PP population per treatment received | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | From 6 hours to 12 hours post-dose |
|
|
|
|
| Secondary | TOTPAR Over 0-6 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief. | PP population per treatment received | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | Up to 6 hours post-dose |
|
|
|
|
| Secondary | TOTPAR 6-12 Hours | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief. | PP population per treatment received | Posted | Least Squares Mean | Standard Error | Scores on a scale * hours | From 6 hours to 12 hours post-dose |
|
|
|
|
| Secondary | Time to First Intake of Rescue Medication | Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment. | PP population per treatment received | Posted | Median | 95% Confidence Interval | Hours | Up to 12 hours post-dose |
|
|
|
|
| Secondary | Pain Intensity Difference (PID) Scores at Each Evaluation | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. | PP population per treatment received | Posted | Mean | Standard Deviation | Scores on a scale | Up to 12 hours post-dose |
|
|
|
| Secondary | Number of Participants by Global Evaluation Scores | Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.' | Subjects who were assessed for this endpoint in PP population per treatment received | Posted | Count of Participants | Participants | Up to 12 hours post-dose |
|
|
|
|
| Secondary | Pain Relief Scores at Each Evaluation | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). | PP population per treatment received | Posted | Mean | Standard Deviation | Scores on a scale | Up to 12 hours post-dose |
|
|
|
| 0 |
| 192 |
| 0 |
| 192 |
| 12 |
| 192 |
| EG001 | Acetaminophen | Participants received one single oral dose of 1000 mg acetaminophen (safety population per treatment received) | 0 | 185 | 0 | 185 | 9 | 185 |
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 3 hours |
|
| 6 hours |
|
| 9 hours |
|
| 12 hours |
|
| Good |
|
| Very good |
|
| Excellent |
|
| 3 hours |
|
| 6 hours |
|
| 9 hours |
|
| 12 hours |
|