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Business decision
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This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine 0.5 mg TID | Experimental | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
|
| Buprenorphine 1.0 mg BID | Experimental | Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. |
|
| Buprenorphine 1.0 mg TID | Experimental | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. |
|
| Placebo | Placebo Comparator | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine Sublingual Spray | Drug | Buprenorphine sublingual spray delivered via single 100 μL spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | Baseline and 0 to 48 hours after Time 0 |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni DeCastro | INSYS Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85027 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
| FG001 | Buprenorphine 1.0 mg BID | Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. |
| FG002 | Buprenorphine 1.0 mg TID | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. |
| FG003 | Placebo | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
| BG001 | Buprenorphine 1.0 mg BID |
| 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 | Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | All randomized participants from the Intent-to-Treat (ITT) Population. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 0 to 48 hours after Time 0 |
Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
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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 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual disturbance | Eye disorders | MedDRA (17.1) | Systematic Assessment |
This study was terminated early by the sponsor due to business reasons (40 participants enrolled out of 312 planned). Due to this early termination 10 outcome measures originally registered as pre-specified secondary are no longer secondaries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Insys Therapeutics, Inc. | 480-500-3105 | gdecastro@insysrx.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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| Placebo | Drug | Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray |
|
| Baseline and 4, 8, 24 and 48 hours after Time 0 |
| NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. | 4, 8, 24 and 48 hours after Time 0 |
| NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | Baseline and 0 to 4 hours after Time 0 |
| NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | Baseline and 0 to 8 hours after Time 0 |
| NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | Baseline and 0 to 24 hours after Time 0 |
| Percentage of Participants Who Used Rescue Medication for Pain | The percentage of participants who needed to take an alternate medication for pain relief during the study. | From Time 0 (first dose of study drug) up to Day 9 |
| Pasadena |
| Maryland |
| 21122 |
| United States |
| Austin | Texas | 78728 | United States |
| Withdrawal by Subject |
|
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
| BG002 | Buprenorphine 1.0 mg TID | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. |
| BG003 | Placebo | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
| OG001 | Buprenorphine 1.0 mg BID | Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. |
| OG002 | Buprenorphine 1.0 mg TID | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. |
| OG003 | Placebo | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. |
|
|
|
| Secondary | NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. | All randomized participants from the ITT Population with data available at each timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4, 8, 24 and 48 hours after Time 0 |
|
|
|
| Secondary | NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0 | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain. | All randomized participants from the ITT Population with data available at each timepoint. | Posted | Mean | Standard Deviation | units on a scale | 4, 8, 24 and 48 hours after Time 0 |
|
|
|
| Secondary | NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | ITT Population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 0 to 4 hours after Time 0 |
|
|
|
|
| Secondary | NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | ITT Population included all randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 0 to 8 hours after Time 0 |
|
|
|
|
| Secondary | NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24) | Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate. | ITT Population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 0 to 24 hours after Time 0 |
|
|
|
|
| Secondary | Percentage of Participants Who Used Rescue Medication for Pain | The percentage of participants who needed to take an alternate medication for pain relief during the study. | ITT Population included all participants who were randomized. | Posted | Number | percentage of participants | From Time 0 (first dose of study drug) up to Day 9 |
|
|
|
| 1 |
| 9 |
| 9 |
| 9 |
| EG001 | Buprenorphine 1.0 mg BID | Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. | 0 | 11 | 11 | 11 |
| EG002 | Buprenorphine 1.0 mg TID | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. | 0 | 10 | 9 | 10 |
| EG003 | Placebo | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. | 0 | 10 | 7 | 10 |
| Burning mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Numbness mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Sore mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Tingling lips | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Tingling tongue | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Xerostomia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Shivering | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory rate decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Temperature elevation | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cramps in leg | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dizzy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Intermittent headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Paresthesia of fingers | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Shakiness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Trembling | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Euphoria | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vivid dreams | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Singultus | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Adhesive tape allergy | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Localised rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pruritus facial | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Wheals | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
|
| 8 Hours |
|
|
| 24 Hours |
|
|
| 48 Hours |
|
|
|
| 8 Hours |
|
|
| 24 Hours |
|
|
| 48 Hours |
|
|
The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. |
| 0.085 |
| LS Mean Difference |
| 8.056 |
| Standard Error of the Mean |
| 4.5331 |
| 2-Sided |
| 95 |
| -1.17 |
| 17.28 |
| Other |
| ANCOVA | The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. | 0.041 | LS Mean Difference | 10.063 | Standard Error of the Mean | 4.7393 | 2-Sided | 95 | 0.42 | 19.70 | Other |
The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. |
| 0.009 |
| LS Mean Difference |
| 21.605 |
| Standard Error of the Mean |
| 7.8429 |
| 2-Sided |
| 95 |
| 5.65 |
| 37.56 |
| Other |
| ANCOVA | The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. | 0.011 | LS Mean Difference | 22.143 | Standard Error of the Mean | 8.1997 | 2-Sided | 95 | 5.46 | 38.83 | Other |
The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. |
| 0.007 |
| LS Mean Difference |
| 50.284 |
| Standard Error of the Mean |
| 17.5979 |
| 2-Sided |
| 95 |
| 14.48 |
| 86.09 |
| Other |
| ANCOVA | The analysis included treatment and site as main effects and Baseline pain intensity as the covariate. | 0.004 | LS Mean Difference | 56.879 | Standard Error of the Mean | 18.3984 | 2-Sided | 95 | 19.45 | 94.31 | Other |