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Primary objective:
To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile measured by VAS.
Secondary objectives:
To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth:
This is a multicenter, double blind, randomized, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.
The patients are assigned to one of two treatment group in 1:1 ratio:
The study consisted of three periods: screening, study treatment and follow-up. The duration of participation of each subject in the study was to be up to 7±1 days and included: screening (up to 4 days), tooth extraction, randomization and study treatment (1 day), and follow-up (2 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OKITASK® | Experimental | Single oral administration of Ketoprofen lysine salt 40 mg granules |
|
| Placebo | Placebo Comparator | Single oral administration of placebo matching granules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OKITASK® | Drug | A single oral dose of OKITASK® 40 mg was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen). The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population. | The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 mm = no pain and 100 mm = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result. | time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment |
| AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population. | The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 = no pain and 100 = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result. | time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time Profile of Pain Intensity Using VAS Scale | This outcome analyzed the evolution and the profile of pain by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable at 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the worse the result. |
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Inclusion Criteria:
Signed Informed Consent Form;
Male and female, from 18 years to 65 years (inclusively);
Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;
Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Lanata, MD | Dompé SpA Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC "Centre for Interdisciplinary Dentistry and Neurology" | Moscow | 119146 | Russia | |||
| Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health |
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There were 73 screened patients in the study. 70 of them were randomized into the OKITASK® or Placebo groups by 35 patients per each group.
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| ID | Title | Description |
|---|---|---|
| FG000 | OKITASK® | Single oral administration of Ketoprofen lysine salt 40 mg granules Ketoprofen: 40 mg KLS granules (corresponding to 25 mg ketoprofen) |
| FG001 | Placebo | Single oral administration of placebo granules Placebo: 0 mg KLS granules |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population: included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketoprofen | Single oral administration of Ketoprofen lysine salt 40 mg granules Ketoprofen: 40 mg KLS granules (corresponding to 25 mg ketoprofen) |
| BG001 | Placebo | Single oral administration of placebo granules Placebo: 0 mg KLS granules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population. | The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 mm = no pain and 100 mm = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Mean | Standard Deviation | mm*min | time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment |
From screening day (-4) to follow up ( day 3 +/- 1), up to day 3 post-dose.
More specifically, adverse events are assessed at:
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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 | OKITASK® | Single oral administration of Ketoprofen lysine salt 40 mg granules Ketoprofen: 40 mg KLS granules (corresponding to 25 mg ketoprofen) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development & Operations | Dompé farmaceutici S.p.A. | +39 02 583831 | clinical.trials@dompe.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2018 | Jul 24, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2018 | Jul 24, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D014098 | Toothache |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The double-blinding is provided by Placebo that is identical to OKITASK® 40 mg granules.
The drug will be packaged and labeled in a manner that will exclude unblinding. IWRS will assign the study drug kit number that should be administrated by the subject.
|
|
| Placebo | Other | A single oral dose of matching Placebo was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained Placebo. The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects. |
|
|
| From time 0 (baseline value of VAS) to 6 hours post-treatment at: 0', 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. |
| Time Profile of Pain Relief Using VAS Scale | This outcome analyzed the evolution of pain relief after administration of OKITASK® and after administration of Placebo, assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain relief - 100 maximum relief imaginable at: 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the best the result. | From time 0 (baseline value of VAS) to 6 hours post-treatment at: 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. |
| AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations | In addition, area under the curve for pain relief assessment since 5 minutes till 6 hours after the drug administration was evaluated. | from 5 min to 6 hours post-dose |
| Time to First Perceptible Relief (TFPR) | TFPR was measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients immediately started a stopwatch, once the patient felt first perceptible pain relief, the stopwatch was stopped. The time between activation and deactivation of a stopwatch defined the outcome measure data. The shortest the time, the better the outcome. Kaplan-Meier estimation of TFPR was expressed by median and 95% CI. | Day 1 |
| Time to Meaningful Pain Relief (TMPR) | TMPR will be measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels meaningful perceptible pain relief, the stopwatch is stopped. The time between activation and deactivation of a stopwatch defines the outcome measure data. | Day 1 |
| Number of Participants With an Overall Assessment Score of "Very Good", "Satisfactory", "Poor" or "Very Poor" on a (Patient's Overall Assessment) on a 5-point Scale | The patients were asked to provide their current overall assessment answering the question "Considering all the ways that the pain affects you, how well are you doing? The patients marked the answer on the 5-point scale: 1 = very good, 2 = good, 3= satisfactory, 4 = poor, 5 = very poor. If a patient takes rescue medication, the Patient's overall assessment will be performed after the last VAS assessment. | Day 1 at 360' or > 60' in case of early discontinuation. |
| Moscow |
| 127473 |
| Russia |
| State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev" | Yaroslavl | Russia |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | OKITASK | Single oral administration of Ketoprofen lysine salt 40 mg granules Ketoprofen: 40 mg KLS granules (corresponding to 25 mg ketoprofen) |
| OG001 | Placebo | Single oral administration of placebo granules Placebo: 0 mg KLS granules |
|
|
|
| Primary | AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population. | The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 = no pain and 100 = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be >30 mm. The higher the score, the worse the result. | The Per protocol population included those patients who had completed the study treatment period, had all assessments for the primary efficacy analysis and considered compliant. The patients were compliant if they did not have any major protocol violations in the course of the study. For the PP population no data could be missing, hence there were no LOCF or other methods applied. | Posted | Mean | Standard Deviation | mm*min | time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment |
|
|
|
|
| Secondary | Time Profile of Pain Intensity Using VAS Scale | This outcome analyzed the evolution and the profile of pain by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable at 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the worse the result. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Mean | Standard Deviation | mm | From time 0 (baseline value of VAS) to 6 hours post-treatment at: 0', 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. |
|
|
|
|
| Secondary | Time Profile of Pain Relief Using VAS Scale | This outcome analyzed the evolution of pain relief after administration of OKITASK® and after administration of Placebo, assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain relief - 100 maximum relief imaginable at: 0' (just before taking the first medication VAS should be >30 mm) and 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240'(4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. The higher the score, the best the result. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Mean | Standard Deviation | mm | From time 0 (baseline value of VAS) to 6 hours post-treatment at: 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration. |
|
|
|
|
| Secondary | AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations | In addition, area under the curve for pain relief assessment since 5 minutes till 6 hours after the drug administration was evaluated. | ITT population included all randomized patients who received at least one dose of study medication and have at least one post-baseline 18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. PP population included those patients who had completed the study treatment period, had all assessments for the primary efficacy analysis and compliant. | Posted | Mean | Standard Deviation | mm*min | from 5 min to 6 hours post-dose |
|
|
|
|
| Secondary | Time to First Perceptible Relief (TFPR) | TFPR was measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients immediately started a stopwatch, once the patient felt first perceptible pain relief, the stopwatch was stopped. The time between activation and deactivation of a stopwatch defined the outcome measure data. The shortest the time, the better the outcome. Kaplan-Meier estimation of TFPR was expressed by median and 95% CI. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Median | 95% Confidence Interval | minutes | Day 1 |
|
|
|
|
| Secondary | Time to Meaningful Pain Relief (TMPR) | TMPR will be measured by stopwatches, a timepiece designed to measure the amount of time that elapses between its activation and deactivation. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels meaningful perceptible pain relief, the stopwatch is stopped. The time between activation and deactivation of a stopwatch defines the outcome measure data. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Median | 95% Confidence Interval | Minutes | Day 1 |
|
|
|
|
| Secondary | Number of Participants With an Overall Assessment Score of "Very Good", "Satisfactory", "Poor" or "Very Poor" on a (Patient's Overall Assessment) on a 5-point Scale | The patients were asked to provide their current overall assessment answering the question "Considering all the ways that the pain affects you, how well are you doing? The patients marked the answer on the 5-point scale: 1 = very good, 2 = good, 3= satisfactory, 4 = poor, 5 = very poor. If a patient takes rescue medication, the Patient's overall assessment will be performed after the last VAS assessment. | The Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study medication and have at least one post-baseline18 efficacy measurement; one patient in the ketoprofen group had missing data of the pain intensity VAS and such data were not replaced according to rules for LOCF; hence no AUC for this patient was calculated. | Posted | Number | participants | Day 1 at 360' or > 60' in case of early discontinuation. |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | Single oral administration of placebo granules Placebo: 0 mg KLS granules | 0 | 35 | 0 | 35 | 1 | 35 |
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Not provided
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| 5min |
|
|
| 10min |
|
|
| 15min |
|
|
| 30min |
|
|
| 45min |
|
|
| 1h |
|
|
| 1,5h |
|
|
| 2h |
|
|
| 3h |
|
|
| 4h |
|
|
| 5h |
|
|
| 6h |
|
|
at 5'
| ANOVA |
The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. |
| 0.685 |
| adjusted least square mean |
| 1.3 |
| 2-Sided |
| 95 |
| -4.9 |
| 7.4 |
| Superiority |
| at 10' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.930 | adjusted least square mean | -0.3 | 2-Sided | 95 | -7.4 | 6.8 | Superiority |
| at 15' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.615 | adjusted least square mean | -2.1 | 2-Sided | 95 | -10.3 | 6.1 | Superiority |
| at 30' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.051 | adjusted least square mean | -8.5 | 2-Sided | 95 | -17.0 | 0 | Superiority |
| at 45' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.043 | adjusted least square mean | -8.4 | 2-Sided | 95 | -16.6 | -0.3 | Superiority |
| at 1h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.023 | adjusted least square mean | -9.0 | 2-Sided | 95 | -16.7 | -1.3 | Superiority |
| at 1.5h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.009 | adjusted least square mean | -10.5 | 2-Sided | 95 | -18.2 | -2.7 | Superiority |
| at 2h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.018 | adjusted least square mean | -9.3 | 2-Sided | 95 | -17.0 | -1.7 | Superiority |
| at 3h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.182 | adjusted least square mean | -5.5 | 2-Sided | 95 | -13.6 | 2.6 | Superiority |
| at 4h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.236 | adjusted least square mean | -4.8 | 2-Sided | 95 | -12.9 | 3.2 | Superiority |
| at 5h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.320 | adjusted least square mean | -3.6 | 2-Sided | 95 | -10.6 | 3.5 | Superiority |
| at 6h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.572 | adjusted least square mean | -2.2 | 2-Sided | 95 | -10.0 | 5.6 | Superiority |
| at 15' |
|
| at 30' |
|
| at 45' |
|
| at 1h |
|
| at 1.5h |
|
| at 2h |
|
| at 3h |
|
| at 4h |
|
| at 5h |
|
| at 6h |
|
at 10'
| ANOVA |
The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. |
| 0.298 |
| adjusted least square mean |
| 4.2 |
| 2-Sided |
| 95 |
| -3.8 |
| 12.3 |
| Superiority |
| at 15' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.112 | adjusted least square mean | 8.9 | 2-Sided | 95 | -2.1 | 19.8 | Superiority |
| at 30' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.003 | adjusted least square mean | 22.3 | 2-Sided | 95 | 7.8 | 36.8 | Superiority |
| at 45' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.008 | adjusted least square mean | 21.2 | 2-Sided | 95 | 5.6 | 36.7 | Superiority |
| at 1h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.018 | adjusted least square mean | 18.7 | 2-Sided | 95 | 3.3 | 34.0 | Superiority |
| at 1.5h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.003 | adjusted least square mean | 22.3 | 2-Sided | 95 | 7.7 | 37.0 | Superiority |
| at 2h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.003 | adjusted least square mean | 22.0 | 2-Sided | 95 | 8.0 | 36.1 | Superiority |
| at 3h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.015 | adjusted least square mean | 16.7 | 2-Sided | 95 | 3.4 | 30.0 | Superiority |
| at 4h | ANOVA | 0.103 | adjusted least square mean | 10.8 | 2-Sided | 95 | -2.2 | 23.9 | Superiority |
| at 5' | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.311 | adjusted least square mean | 5.9 | 2-Sided | 95 | -5.6 | 17.5 | Superiority |
| at 6h | ANOVA | The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement. | 0.638 | adjusted least square mean | 2.8 | 2-Sided | 95 | -9.0 | 14.5 | Superiority |
| PP population |
|
|
| 0.009 |
| Superiority |
| Satisfactory |
|
| poor |
|
| no data |
|