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| ID | Type | Description | Link |
|---|---|---|---|
| C1211009 | Other Identifier | Alias Study Number |
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This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | DIC075V (IV diclofenac) |
|
| B | Active Comparator | IV Ketorolac |
|
| C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Diclofenac | Drug | IV Diclofenac q6h |
| |
| IV ketorolac |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the Pain Intensity Differences (SPID) Over 24 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction. | Over 24 hours post first dose |
| Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction. | Over 48 hours post first dose |
| Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction. | Over 72 hours post first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Differences (PID) Over Time | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). PID score range at any post dose (post baseline) evaluation time point was -100 to 100. A positive difference score is indicative of improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| Arizona Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29492863 | Derived | Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3. |
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Total 432 participants signed the inform consent form (ICF). Out of which 155 participants were not admitted into the study, 277 actually enrolled into the study and assigned to study treatment.
Participants who required elective general orthopedic surgery were eligible for participation in this study. Within 6 hours after completion of surgery, participants who experienced moderate to severe pain, as measured by a 0-100 millimeter (mm) visual analog scale (VAS) with pain intensity (PI) score of greater than or equal to (>=) 50 mm and who met all eligibility criteria were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac (DIC075V) | Participants at high risk (weighing less than [<] 50 killogram [k]), age >= 65 years, elevated nonsteroidal anti-inflammatory drugs [NSAID]-related gastrointestinal [GI] risk factors, or with hepatic or renal impairment) received DIC075V 18.75 milligram (mg). Participants without any risk factor and weighing greater than (>) 95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as intravenous (IV) bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| FG001 | Ketorolac | Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| FG002 | Placebo | Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-To-Treat (ITT) population included all participants who were randomized into the study and who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac (DIC075V) | Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| 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 the Pain Intensity Differences (SPID) Over 24 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | Over 24 hours post first dose |
|
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Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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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 | Diclofenac (DIC075V) | Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | 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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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
IV ketorolac q6h |
|
| Placebo | Drug | Placebo q6h |
|
| Sum of the Pain Intensity Differences (SPID) Over 96 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction. | Over 96 hours post first dose |
| Sum of the Pain Intensity Differences (SPID) Over 120 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction. | Over 120 hours post first dose |
| Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose |
| Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | Pain intensity was measured on a 0 to 100 mm VAS, larger values indicate greater pain intensity. In this outcome measure, percentage of participants attaining >= 30 % reduction in pain intensity from baseline to specified time points was reported. | Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose |
| Total Pain Relief (TOTPAR) | Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. TOTPAR over specified time interval was calculated as area under pain relief curve over specified time intervals using trapezoidal approximation. For 0-24 hours score range was 0-2400, for 0-48 hours score range was 0- 4800, for 0-96 hours score range was 0-9600 and for 0-120 hours score range was 0-12000. Higher TOTPAR values indicated more relief. | 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose |
| Visual Analog Pain Relief Values Over the Time | Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. | 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose |
| Time From Administration of Study Drug to Administration of Rescue Medication | Time from administration of study drug to administration of rescue medication were censored at time of last pain assessment for participants who did not receive rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. | Maximum up to 5 days |
| Cumulative Amount of Rescue Medication | In this outcome measure, cumulative amount of rescue medication used over 0-24, 0-48, 0-72, 0-96, and 0-120 hours were reported. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. | 0-24, 0-48, 0-72, 0-96 and 0-120 hours |
| Number of Participants According to Frequency of Use of Rescue Medication | In this outcome measure, number of participants are reported according to number of times they received rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. Only those categories with at least one nonzero value are reported. | 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose |
| Participant Global Evaluation Over Time | Participants global evaluation of study medication was accessed on a scale ranging from scale 0 to 4 where 0= poor, 1= fair, 2= good, 3= very good, 4= excellent where higher score represented better outcome. | 0-24, 0-48, 0-120 hours post-dose |
| Time to Perceptible Relief | Participants were instructed to stop the first stopwatch at the onset of perceptible pain relief after first dose. Event times of participants not reporting perceptible relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. | Within 6 hours of first dose on Day 1 |
| Time to Meaningful Relief | Participants were instructed to stop the second stopwatch at the onset of meaningful pain relief after first dose. Event times of participants not reporting meaningful relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. | Within 6 hours of first dose on Day 1 |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Accurate Clinical Trials | San Clemente | California | 92672 | United States |
| East Coast Clincial Research | Ft. Pierce | Florida | 34950 | United States |
| Outcomes Research Institute | Louisville | Kentucky | 40202 | United States |
| American Institute of Healthcare and Fitness | Raleigh | North Carolina | 27615 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16081 | United States |
| SCIREX | Austin | Texas | 78705 | United States |
| Investigator Decision |
|
| Adverse Event |
|
| Protocol Violation |
|
| Other |
|
| BG001 | Ketorolac | Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| BG002 | Placebo | Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants at high risk (weighing <50 k), age >= 65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received DIC075V 18.75 mg. Participants without any risk factor and weighing >95 kg received DIC075V 50 mg. Participants weighing >95 kg with any risk factor received DIC075V 18.75 mg. All other participants received DIC075V 37.5 mg. DIC075V was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| OG001 | Ketorolac | Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
| OG002 | Placebo | Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. |
|
|
|
| Primary | Sum of the Pain Intensity Differences (SPID) Over 48 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | Over 48 hours post first dose |
|
|
|
|
| Primary | Sum of the Pain Intensity Differences (SPID) Over 72 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | Over 72 hours post first dose |
|
|
|
|
| Primary | Sum of the Pain Intensity Differences (SPID) Over 96 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | Over 96 hours post first dose |
|
|
|
|
| Primary | Sum of the Pain Intensity Differences (SPID) Over 120 Hours | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | Over 120 hours post first dose |
|
|
|
|
| Secondary | Pain Intensity Differences (PID) Over Time | Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). PID score range at any post dose (post baseline) evaluation time point was -100 to 100. A positive difference score is indicative of improvement. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points. | Posted | Mean | Standard Deviation | mm | Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose |
|
|
|
| Secondary | Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity | Pain intensity was measured on a 0 to 100 mm VAS, larger values indicate greater pain intensity. In this outcome measure, percentage of participants attaining >= 30 % reduction in pain intensity from baseline to specified time points was reported. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Number | Percentage of participants | Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose |
|
|
|
| Secondary | Total Pain Relief (TOTPAR) | Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. TOTPAR over specified time interval was calculated as area under pain relief curve over specified time intervals using trapezoidal approximation. For 0-24 hours score range was 0-2400, for 0-48 hours score range was 0- 4800, for 0-96 hours score range was 0-9600 and for 0-120 hours score range was 0-12000. Higher TOTPAR values indicated more relief. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm*hours | 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose |
|
|
|
| Secondary | Visual Analog Pain Relief Values Over the Time | Pain relief values at specified time points were measured on a 0 to 100 mm VAS, where higher values indicate greater pain relief. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm | 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose |
|
|
|
| Secondary | Time From Administration of Study Drug to Administration of Rescue Medication | Time from administration of study drug to administration of rescue medication were censored at time of last pain assessment for participants who did not receive rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using worst observation carried forward (WOCF) recorded over prior six hours (including baseline, if appropriate) in this outcome measure. | Posted | Median | 95% Confidence Interval | Minutes | Maximum up to 5 days |
|
|
|
| Secondary | Cumulative Amount of Rescue Medication | In this outcome measure, cumulative amount of rescue medication used over 0-24, 0-48, 0-72, 0-96, and 0-120 hours were reported. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific rows. Missing data was imputed using WOCF recorded over prior six hours (including baseline, if appropriate) in this outcome measure. | Posted | Mean | Standard Deviation | mg | 0-24, 0-48, 0-72, 0-96 and 0-120 hours |
|
|
|
| Secondary | Number of Participants According to Frequency of Use of Rescue Medication | In this outcome measure, number of participants are reported according to number of times they received rescue medication. Rescue medication was additional pain medication, available to participants if they did not receive pain relief from the study drug. Rescue medication available during this study was IV morphine. Only those categories with at least one nonzero value are reported. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Missing data was imputed using WOCF recorded over prior six hours (including baseline, if appropriate) in this outcome measure. | Posted | Count of Participants | Participants | 0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose |
|
|
|
| Secondary | Participant Global Evaluation Over Time | Participants global evaluation of study medication was accessed on a scale ranging from scale 0 to 4 where 0= poor, 1= fair, 2= good, 3= very good, 4= excellent where higher score represented better outcome. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific rows. | Posted | Mean | Standard Deviation | Units on a scale | 0-24, 0-48, 0-120 hours post-dose |
|
|
|
| Secondary | Time to Perceptible Relief | Participants were instructed to stop the first stopwatch at the onset of perceptible pain relief after first dose. Event times of participants not reporting perceptible relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Median | Full Range | Minutes | Within 6 hours of first dose on Day 1 |
|
|
|
| Secondary | Time to Meaningful Relief | Participants were instructed to stop the second stopwatch at the onset of meaningful pain relief after first dose. Event times of participants not reporting meaningful relief were censored at 6 hours; event times of participants who withdrew or were administered rescue medication were censored at time of withdrawal or rescue. Kaplan-Meier estimate was used for analysis. | ITT population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Minutes | Within 6 hours of first dose on Day 1 |
|
|
|
| 7 |
| 145 |
| 109 |
| 145 |
| EG001 | Ketorolac | Participants at high risk (weighing <50 k, >=65 years, elevated NSAID-related GI risk factors, or with hepatic or renal impairment) received ketorolac tromethamine 15 mg. Participants without any risk factor and weighing >95 kg received ketorolac tromethamine 30 mg. Participants weighing >95 kg with any risk factor received ketorolac tromethamine 15 mg. All other participants received ketorolac tromethamine 30 mg. Ketorolac tromethamine was administered as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. | 4 | 60 | 46 | 60 |
| EG002 | Placebo | Participants received saline as placebo as IV bolus every 6 hours for up to 5 days. Participants returned to the clinic for a safety follow-up 5-9 days after discharge and had a safety follow-up telephone call 30-37 days after the last study drug administration. | 3 | 72 | 60 | 72 |
| Blindness unilateral | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Eye oedema | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site inflammation | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site vesicles | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Confusional state | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Disorientation | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash maculovesicular | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Post procedural drainage | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | 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.
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| At 10 minutes |
|
|
| At 15 minutes |
|
|
| At 30 minutes |
|
|
| At 45 minutes |
|
|
| At 1 hour |
|
|
| At 2 hours |
|
|
| At 3 hours |
|
|
| At 5 hours |
|
|
| At 6 hours |
|
|
| At 9 hours |
|
|
| At 12 hours |
|
|
| At 15 hours |
|
|
| At 18 hours |
|
|
| At 21 hours |
|
|
| At 24 hours |
|
|
| At 48 hours |
|
|
| At 72 hours |
|
|
| At 96 hours |
|
|
| At 120 hours |
|
|
| Title | Measurements |
|---|---|
|
| At 1 hour |
|
| At 24 hours |
|
| At 48 hours |
|
| At 72 hours |
|
| At 90 hours |
|
| At 120 hours |
|
|
| 0-72 hours |
|
| 0-96 hours |
|
| 0-120 hours |
|
|
| At 15 minutes |
|
| At 30 minutes |
|
| At 45 minutes |
|
| At 1 hour |
|
| At 2 hours |
|
| At 3 hours |
|
| At 5 hours |
|
| At 6 hours |
|
| At 9 hours |
|
| At 12 hours |
|
| At 15 hours |
|
| At 18 hours |
|
| At 21 hours |
|
| At 24 hours |
|
| At 48 hours |
|
| At 72 hours |
|
| At 96 hours |
|
| At 120 hours |
|
| 0-48 hours |
|
|
| 0-72 hours |
|
|
| 0-96 hours |
|
|
| 0-120 hours |
|
|
| Title | Measurements |
|---|---|
|
| 0 - 24 Hours: 2 |
|
| 0 - 24 Hours: 3 |
|
| 0 - 24 Hours: 4 |
|
| 0 - 24 Hours: 5 |
|
| 0 - 24 Hours: 6 |
|
| 0 - 24 Hours: 7 |
|
| 0 - 24 Hours: 8 |
|
| 0 - 24 Hours: 9 |
|
| 0 - 24 Hours: 11 |
|
| 0 - 24 Hours: 12 |
|
| 0 - 24 Hours: 13 |
|
| 0 - 24 Hours: 14 |
|
| 0 - 24 Hours: 15 |
|
| 0-48 hours: 0 |
|
| 0-48 hours: 1 |
|
| 0-48 hours: 2 |
|
| 0-48 hours: 3 |
|
| 0-48 hours: 4 |
|
| 0-48 hours: 5 |
|
| 0-48 hours: 6 |
|
| 0-48 hours: 7 |
|
| 0-48 hours: 8 |
|
| 0-48 hours: 9 |
|
| 0-48 hours: 10 |
|
| 0-48 hours: 11 |
|
| 0-48 hours: 12 |
|
| 0-48 hours: 13 |
|
| 0-48 hours: 14 |
|
| 0-48 hours: 15 |
|
| 0-48 hours: 17 |
|
| 0-48 hours: 20 |
|
| 0-72 hours: 0 |
|
| 0-72 hours: 1 |
|
| 0-72 hours: 2 |
|
| 0-72 hours: 3 |
|
| 0-72 hours: 4 |
|
| 0-72 hours: 5 |
|
| 0-72 hours: 6 |
|
| 0-72 hours: 7 |
|
| 0-72 hours: 8 |
|
| 0-72 hours: 9 |
|
| 0-72 hours: 10 |
|
| 0-72 hours: 11 |
|
| 0-72 hours: 12 |
|
| 0-72 hours: 13 |
|
| 0-72 hours: 14 |
|
| 0-72 hours: 15 |
|
| 0-72 hours: 17 |
|
| 0-72 hours: 19 |
|
| 0-72 hours: 20 |
|
| 0-72 hours: 21 |
|
| 0-96 hours: 0 |
|
| 0-96 hours: 1 |
|
| 0-96 hours: 2 |
|
| 0-96 hours: 3 |
|
| 0-96 hours: 4 |
|
| 0-96 hours: 5 |
|
| 0-96 hours: 6 |
|
| 0-96 hours: 7 |
|
| 0-96 hours: 8 |
|
| 0-96 hours: 9 |
|
| 0-96 hours: 10 |
|
| 0-96 hours: 11 |
|
| 0-96 hours: 12 |
|
| 0-96 hours: 13 |
|
| 0-96 hours: 14 |
|
| 0-96 hours: 15 |
|
| 0-96 hours: 17 |
|
| 0-96 hours: 19 |
|
| 0-96 hours: 20 |
|
| 0-96 hours: 21 |
|
| 0-120 hours: 0 |
|
| 0-120 hours: 1 |
|
| 0-120 hours: 2 |
|
| 0-120 hours: 3 |
|
| 0-120 hours: 4 |
|
| 0-120 hours: 5 |
|
| 0-120 hours: 6 |
|
| 0-120 hours: 7 |
|
| 0-120 hours: 8 |
|
| 0-120 hours: 9 |
|
| 0-120 hours: 10 |
|
| 0-120 hours: 11 |
|
| 0-120 hours: 12 |
|
| 0-120 hours: 13 |
|
| 0-120 hours: 14 |
|
| 0-120 hours: 15 |
|
| 0-120 hours: 17 |
|
| 0-120 hours: 19 |
|
| 0-120 hours: 20 |
|
| 0-120 hours: 21 |
|
| 0-48 Hours |
|
|
| 0-120 Hours |
|
|