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| ID | Type | Description | Link |
|---|---|---|---|
| JNS013-JPN-03 |
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The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.
This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol plus Acetaminophen and Placebo | Experimental | Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
|
| Tramadol and Placebo | Experimental | Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
|
| Acetaminophen and Placebo | Experimental | Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Hydrochloride | Drug | Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief Based on Numerical Rating Scale (NRS) Score | Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. | Baseline up to 8 hours post-administration of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isehara | Japan | |||||
Not provided
| Label | URL |
|---|---|
| A confirmatory study of JNS013 in patients with post-tooth-extraction pain | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| FG001 | Tramadol Hydrochloride and Placebo | Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| FG002 | Acetaminophen and Placebo | Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| 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 | Total Pain Relief Based on Numerical Rating Scale (NRS) Score | Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. | Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | 8 hours |
|
Baseline up to Day 8
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug hypersensitivity | Immune system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alveolar osteitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | JANSSEN PHARMACEUTICAL. K.K. , Neuroscience Department, Clinical Science Division | +81-3-4411-5509 |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
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| Acetaminophen | Drug | Acetaminophen two oral capsules will be administered once as 650 mg. |
|
| Placebo | Drug | Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen. |
|
| Tramadol plus Acetaminophen | Drug | Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively. |
|
|
| Sum of Pain Intensity Difference (SPID) | Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). | Baseline up to 8 hours post-administration of study treatment |
| Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). | Baseline up to 8 hours post-administration of study treatment |
| Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response. | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
| Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment | The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
| Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
| Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
| Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment. | Baseline up to 8 hours post-administration of study treatment |
| Percentage of Participants With Categorical Score for Patient Impressions | Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work. | Baseline up to 8 hours post-administration of study treatment |
| Number of Participants Treated With a Relief Analgesic | Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness. | Baseline up to 8 hours post-administration of study treatment |
| Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful & could not be assessed" for overall evaluation (OE). | Baseline up to 8 hours post-administration of study treatment |
| Kitakyushu |
| Japan |
| Kumamoto | Japan |
| Ohta-Ku | Japan |
| Osaka | Japan |
| Sapporo | Japan |
| Shimotsuga | Japan |
| Shimotsuke | Japan |
| Tokyo | Japan |
| Yokohama | Japan |
| Yokosuka | Japan |
| Worsening of the symptoms |
|
| BG001 | Tramadol Hydrochloride and Placebo | Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| BG002 | Acetaminophen and Placebo | Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Visual Analog Scale (VAS) Score | Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | Tramadol Hydrochloride and Placebo | Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
| OG002 | Acetaminophen and Placebo | Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). |
|
|
|
| Secondary | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Sum of Pain Intensity Difference (SPID) | Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
|
|
|
| Secondary | Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment | The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
|
|
|
| Secondary | Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
|
|
|
| Secondary | Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment | Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Mean | Standard Deviation | Units on a scale | 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment |
|
|
|
| Secondary | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment. | FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Minutes | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Percentage of Participants With Categorical Score for Patient Impressions | Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Number | Percentage of participants | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Number of Participants Treated With a Relief Analgesic | Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness. | FAS population included all the participants who received the study treatment and had efficacy assessment data. | Posted | Number | Participants | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| Secondary | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful & could not be assessed" for overall evaluation (OE). | FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Percentage of participants | Baseline up to 8 hours post-administration of study treatment |
|
|
|
| 0 |
| 132 |
| 82 |
| 132 |
| EG001 | Tramadol Hydrochloride and Placebo | Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). | 0 | 66 | 40 | 66 |
| EG002 | Acetaminophen and Placebo | Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). | 1 | 130 | 52 | 130 |
| Post procedural infection | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA Version 11.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 11.1 | Non-systematic Assessment |
|
The only disclosure restriction on the Principal Investigator is that the Sponsor can review results communications prior to public release.
| D010335 | Pathologic Processes |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
|
|
| Change at Hour 2 |
|
| Change at Hour 3 |
|
| Change at Hour 4 |
|
| Change at Hour 5 |
|
| Change at Hour 6 |
|
| Change at Hour 7 |
|
| Change at Hour 8 |
|
|
| PID:Change at Hour 2 |
|
| PID:Change at Hour 3 |
|
| PID:Change at Hour 4 |
|
| PID:Change at Hour 5 |
|
| PID:Change at Hour 6 |
|
| PID:Change at Hour 7 |
|
| PID:Change at Hour 8 |
|
|
| PAR:Change at Hour 2 |
|
| PAR:Change at Hour 3 |
|
| PAR:Change at Hour 4 |
|
| PAR:Change at Hour 5 |
|
| PAR:Change at Hour 6 |
|
| PAR:Change at Hour 7 |
|
| PAR:Change at Hour 8 |
|
|
| PRID:Change at Hour 2 |
|
| PRID:Change at Hour 3 |
|
| PRID:Change at Hour 4 |
|
| PRID:Change at Hour 5 |
|
| PRID:Change at Hour 6 |
|
| PRID:Change at Hour 7 |
|
| PRID:Change at Hour 8 |
|
|
|
| Worked a little |
|
| Didn't work |
|
|
| PS:somewhat effective (n=107, 46, 113) |
|
| PS:ineffective (n=107, 46, 113) |
|
| SPR:very effective (n=107, 46, 113) |
|
| SPR:effective (n=107, 46, 113) |
|
| SPR:somewhat effective (n=107, 46, 113) |
|
| SPR:ineffective (n=107, 46, 113) |
|
| DPR:very effective (n=41, 14, 53) |
|
| DPR:effective (n=41, 14, 53) |
|
| DPR:somewhat effective (n=41, 14, 53) |
|
| DPR:ineffective (n=41, 14, 53) |
|
| GE:very effective (n=107, 46, 113) |
|
| GE:effective (n=107, 46, 113) |
|
| GE:somewhat effective (n=107, 46, 113) |
|
| GE:ineffective (n=107, 46, 113) |
|
| OE:Extremely useful (n=107, 46, 113) |
|
| OE:useful (n=107, 46, 113) |
|
| OE:not useful (n=107, 46, 113) |
|
| OE:could not be assessed (n=107, 46, 113) |
|