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| ID | Type | Description | Link |
|---|---|---|---|
| I6H-MC-MCBC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Part A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery. Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
|
| 30 milligrams (mg) LY3023703 | Experimental | Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery. Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
|
| 400 mg Celecoxib | Active Comparator | Part A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control). Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B. Celecoxib was not administered in Part B. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| LY3023703 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS | Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline. | 0 to 8 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose | TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78705 |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants were randomized to treatment groups when their dental pain intensity post oral surgery was moderate (or severe) as reported on a categorical 4-point scale: 0 (absent) to 3 (severe) and were marked on a 100 millimeter (mm) straight line visual analog scale (VAS) with a pain score ≥40 mm: 0 mm (no pain) to 100 mm (worst pain imaginable).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - LY3023703 | LY3023703: Administered orally once as a 30-milligrams (mg) capsule post dental surgery. |
| FG001 | Part A - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control). |
| FG002 | Part A - Placebo | Placebo: Administered orally once as a capsule post dental surgery. |
| FG003 | Part B - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. |
| FG004 | Part B - Placebo | Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement. |
| FG005 | Pre-Part B - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. Prior to Part B, there was a technique transfer and training conducted to allow the site to develop proficiency in dialysate placement, collection and maintenance techniques. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule post dental surgery. |
| BG001 | Part A - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control). |
| 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 | Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS | Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline. | Full Analysis Set (FAS): Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 postdose efficacy assessment. Pain assessments after rescue medication were imputed using last observation carried forward (LOCF) from the pain assessment prior to rescue therapy. | Posted | Least Squares Mean | 95% Confidence Interval | mm | 0 to 8 h post-dose |
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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 | Part A - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule post dental surgery. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
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| Drug |
Administered orally |
|
|
| Celecoxib | Drug | Administered orally |
|
| 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose |
| Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS | Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: [area under the change in pain intensity versus time curve] / [time period that is (i.e.) 24 h for 0 to 24 h endpoint]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. | Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose |
| Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale | The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline. There were no planned efficacy analysis for Pre-Part B per protocol. | 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose |
| Time to First Use of Rescue Medication | Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. | Study drug administration to first use of rescue medication (0 to 24 h post-dose) |
| Part A: Time to Onset of First Perceptible Pain Relief | Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received. | Study drug administration to first perceptible pain relief (0 to 24 h post-dose) |
| Part A: Time to Onset of Meaningful Pain Relief | Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received. | Study drug administration to meaningful pain relief (0 to 24 h post-dose) |
| Part A: Patient Global Impression of Improvement (PGI-I) Scale Score | PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects. | 2, 4, 8, 12 and 24 h post-dose |
| United States |
| BG002 | Part A - Placebo | Placebo: Administered orally once as a capsule post dental surgery. |
| BG003 | Part B - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. |
| BG004 | Part B - Placebo | Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement. |
| BG005 | Pre-Part B - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| VAS Pain Score at Post-Surgery Pre-Randomization | A100-mm straight line is presented to the participant, with anchors of 0 mm at one end (no pain) and 100 mm at the other end (worst pain imaginable). The participant marks the line at the point that corresponds with his or her perceived intensity of pain. | Mean | Standard Deviation | mm |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Part A - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule post dental surgery. |
| OG001 | Part A - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control). |
| OG002 | Part A - Placebo | Placebo: Administered orally once as a capsule post dental surgery. |
|
|
|
| Secondary | Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose | TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. | FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy excluding Pre-Part B. | Posted | Least Squares Mean | 95% Confidence Interval | pain relief * h | 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose |
|
|
|
|
| Secondary | Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS | Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: [area under the change in pain intensity versus time curve] / [time period that is (i.e.) 24 h for 0 to 24 h endpoint]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. | FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose |
|
|
|
|
| Secondary | Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale | The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline. There were no planned efficacy analysis for Pre-Part B per protocol. | FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose |
|
|
|
|
| Secondary | Time to First Use of Rescue Medication | Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol. | FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=5, Celecoxib=18, Placebo=12, Part B: LY3023703=0, Placebo=2. | Posted | Median | 95% Confidence Interval | h | Study drug administration to first use of rescue medication (0 to 24 h post-dose) |
|
|
|
|
| Secondary | Part A: Time to Onset of First Perceptible Pain Relief | Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received. | FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=11, Celecoxib=2, Placebo=9. | Posted | Median | 95% Confidence Interval | h | Study drug administration to first perceptible pain relief (0 to 24 h post-dose) |
|
|
|
|
| Secondary | Part A: Time to Onset of Meaningful Pain Relief | Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received. | FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A LY3023703=24, Celecoxib=2, Placebo=15. | Posted | Median | 95% Confidence Interval | h | Study drug administration to meaningful pain relief (0 to 24 h post-dose) |
|
|
|
|
| Secondary | Part A: Patient Global Impression of Improvement (PGI-I) Scale Score | PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects. | Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose PGI-I assessment. Participants who received rescue medication were not included in the specific timepoints post administration of rescue medication. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 2, 4, 8, 12 and 24 h post-dose |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | Part A - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control). | 0 | 31 | 4 | 31 |
| EG002 | Part A - Placebo | Placebo: Administered orally once as a capsule post dental surgery. | 0 | 30 | 6 | 30 |
| EG003 | Part B - LY3023703 | LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. | 0 | 15 | 4 | 15 |
| EG004 | Part B - Placebo | Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement. | 0 | 15 | 8 | 15 |
| EG005 | Pre-Part B - Celecoxib | Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. | 0 | 3 | 0 | 3 |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 0 to 6 h |
|
| 0 to 8 h |
|
| 0 to 12 h |
|
| 0 to 24 h |
|
| Mean Difference (Final Values) |
| 4.5 |
| 2-Sided |
| 95 |
| 2.9 |
| 6.0 |
95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h. |
| Superiority or Other (legacy) |
| Mean Difference (Final Values) | -5.9 | 2-Sided | 95 | -7.4 | -4.3 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -2.5 | 2-Sided | 95 | -5.2 | 0.2 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 7.1 | 2-Sided | 95 | 4.4 | 9.8 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -9.6 | 2-Sided | 95 | -12.2 | -6.9 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -4.0 | 2-Sided | 95 | -7.9 | -0.1 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 9.2 | 2-Sided | 95 | 5.3 | 13.0 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -13.1 | 2-Sided | 95 | -16.9 | -9.3 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -6.8 | 2-Sided | 95 | -13.2 | 0.5 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 12.9 | 2-Sided | 95 | 6.6 | 19.2 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -19.7 | 2-Sided | 95 | -25.9 | -13.5 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -16.3 | 2-Sided | 95 | -30.8 | -2.0 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 23.1 | 2-Sided | 95 | 9.0 | 37.2 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -39.4 | 2-Sided | 95 | -53.2 | -25.3 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -1.5 | 1.6 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -2.9 | 2.4 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -4.7 | 3.1 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -2.1 | 2-Sided | 95 | -8.3 | 4.1 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -7.0 | 2-Sided | 95 | -21.4 | 7.6 | 95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h. | Superiority or Other (legacy) |
| 0 to 6 h |
|
| 0 to 8 h |
|
| 0 to 12 h |
|
| 0 to 24 h |
|
| Mean Difference (Final Values) |
| -32.0 |
| 2-Sided |
| 95 |
| -41.5 |
| -22.4 |
95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h. |
| Superiority or Other (legacy) |
| Mean Difference (Final Values) | 37.3 | 2-Sided | 95 | 27.8 | 46.5 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 7.3 | 2-Sided | 95 | -2.9 | 17.6 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -35.1 | 2-Sided | 95 | -45.6 | -24.6 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 42.5 | 2-Sided | 95 | 32.1 | 52.7 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 10.7 | 2-Sided | 95 | -1.0 | 23.0 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -32.7 | 2-Sided | 95 | -45.1 | -20.3 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 43.5 | 2-Sided | 95 | 31.3 | 55.5 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 12.4 | 2-Sided | 95 | -1.6 | 26.2 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -30.2 | 2-Sided | 95 | -44.0 | -16.0 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 42.6 | 2-Sided | 95 | 28.6 | 56.5 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 1.6 | 2-Sided | 95 | -9.7 | 12.9 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 3.5 | 2-Sided | 95 | -9.8 | 16.8 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 4.5 | 2-Sided | 95 | -9.9 | 19.0 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 5.9 | 2-Sided | 95 | -9.2 | 21.1 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 7.8 | 2-Sided | 95 | -8.4 | 24.2 | 95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h. | Superiority or Other (legacy) |
| 0 to 6 h |
|
| 0 to 8 h |
|
| 0 to 12 h |
|
| 0 to 24 h |
|
| Mean Difference (Final Values) |
| -2.9 |
| 2-Sided |
| 95 |
| -4.1 |
| -1.7 |
95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h. |
| Superiority or Other (legacy) |
| Mean Difference (Final Values) | 3.5 | 2-Sided | 95 | 2.3 | 4.8 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -0.9 | 3.2 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -4.8 | 2-Sided | 95 | -6.8 | -2.7 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 5.9 | 2-Sided | 95 | 3.8 | 8.0 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 1.9 | 2-Sided | 95 | -1.0 | 4.8 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -6.1 | 2-Sided | 95 | -9.0 | -3.3 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 8.0 | 2-Sided | 95 | 5.1 | 10.9 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 3.4 | 2-Sided | 95 | -1.3 | 8.1 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -8.2 | 2-Sided | 95 | -12.9 | -3.5 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 11.6 | 2-Sided | 95 | 7.0 | 16.5 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 7.8 | 2-Sided | 95 | -2.6 | 18.3 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -14.1 | 2-Sided | 95 | -24.7 | -3.6 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 21.9 | 2-Sided | 95 | 11.5 | 32.2 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -1.6 | 1.0 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | -0.0 | 2-Sided | 95 | -2.2 | 2.1 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 0.2 | 2-Sided | 95 | -2.9 | 3.3 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | -3.9 | 5.7 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h. | Superiority or Other (legacy) |
| Mean Difference (Final Values) | 4.1 | 2-Sided | 95 | -6.8 | 15.0 | 95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h. | Superiority or Other (legacy) |
| Cox Proportional Hazard |
| 0.34 |
| 2-Sided |
| 95 |
| 0.16 |
| 0.72 |
HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. |
| Superiority or Other (legacy) |
| Cox Proportional Hazard | 5.48 | 2-Sided | 95 | 2.69 | 11.16 | HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. | Superiority or Other (legacy) |
| Cox Proportional Hazard | 1.22 | 2-Sided | 95 | 0.57 | 2.59 | HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. | Superiority or Other (legacy) |
| Cox Proportional Hazard |
| 2.15 |
| 2-Sided |
| 95 |
| 1.19 |
| 3.88 |
HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. |
| Superiority or Other (legacy) |
| Cox Proportional Hazard | 0.36 | 2-Sided | 95 | 0.19 | 0.67 | HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. | Superiority or Other (legacy) |
| Cox Proportional Hazard |
| 4.16 |
| 2-Sided |
| 95 |
| 2.04 |
| 8.47 |
HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. |
| Superiority or Other (legacy) |
| Cox Proportional Hazard | 0.08 | 2-Sided | 95 | 0.03 | 0.21 | HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects. | Superiority or Other (legacy) |
| 4 h |
|
|
| 8 h |
|
|
| 12 h |
|
|
| 24 h |
|
|