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The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine 0.5 mg TID | Experimental | Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days. |
|
| Buprenorphine 0.25 mg TID | Experimental | Participants received buprenorphine 0.25 mg sublingual spray TID for two days. |
|
| Buprenorphine 0.125 mg TID | Experimental | Participants received buprenorphine 0.125 mg sublingual spray TID for two days. |
|
| Placebo | Placebo Comparator | Participants received placebo-matching buprenorphine sublingual spray TID for two days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | 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 |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Anaheim Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days. |
| FG001 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days. |
| FG002 | Buprenorphine 0.25 mg TID | Participants received buprenorphine 0.25 mg sublingual spray TID for two days. |
| FG003 | Buprenorphine 0.125 mg TID | Participants received buprenorphine 0.125 mg sublingual spray TID for two days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population included all participants who were treated with the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days. |
| BG001 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days. |
| 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 who did not have missing SPID-48 values. Missing SPID-48 data were not imputed. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 0 to 48 hours after Time 0 |
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 | Placebo | Participants received placebo-matching buprenorphine sublingual (under the tongue) spray TID for two days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Insys Therapeutics, Inc. | 480-500-3105 | gdecastro@insysrx.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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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 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) 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) 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 [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate. | Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0 |
| Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0 | TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity. | 4, 8, 24 and 48 hours after Time 0 |
| Time to Onset of Analgesia | Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped. | From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes) |
| Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0 | Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed. | 4, 8, 24 and 48 hours after Time 0 (first dose of study drug) |
| Percentage of Participants With Peak Scores in Each Pain Relief Category | Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported. | From Time 0 (first dose of study drug) up to 48 hours |
| Time to Peak Pain Relief | Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment. | From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes) |
| Time to First Perceptible Pain Relief | Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. | From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes) |
| Time to Meaningful Pain Relief | Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. | From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes) |
| Percentage of Participants Using Rescue Medication for Pain | The percentage of participants who needed to take an alternate medication for pain relief during the treatment period. | From Time 0 (first dose of study drug) up to 48 hours |
| Time to First Use of Rescue Medication for Pain | Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment. | From Time 0 to time of first use of rescue medication (up to 280 minutes) |
| Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours | Total use of rescue medication is defined as the number of times a participant took rescue medication. | Over 24 and 48 hours after Time 0 (first dose of study drug) |
| Participant's Global Evaluation of Study Drug | Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported. | End of treatment (Day 3) or early termination |
| Anaheim |
| California |
| 92801 |
| United States |
| Chesapeake Research Group | Pasadena | Maryland | 21122 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Buprenorphine 0.25 mg TID | Participants received buprenorphine 0.25 mg sublingual spray TID for two days. |
| BG003 | Buprenorphine 0.125 mg TID | Participants received buprenorphine 0.125 mg sublingual spray TID for two days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
|
| 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 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) 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) 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 [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an 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 who did not have missing SPID values. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0 |
|
|
|
| Secondary | Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0 | TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity. | All randomized participants from the ITT Population with data available at each timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | 4, 8, 24 and 48 hours after Time 0 |
|
|
|
| Secondary | Time to Onset of Analgesia | Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped. | All randomized participants from the ITT Population. | Posted | Median | 95% Confidence Interval | minutes | From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes) |
|
|
|
| Secondary | Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0 | Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed. | All randomized participants from the ITT Population | Posted | Number | percentage of participants | 4, 8, 24 and 48 hours after Time 0 (first dose of study drug) |
|
|
|
| Secondary | Percentage of Participants With Peak Scores in Each Pain Relief Category | Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported. | All randomized participants from the ITT Population | Posted | Number | percentage of participants | From Time 0 (first dose of study drug) up to 48 hours |
|
|
|
| Secondary | Time to Peak Pain Relief | Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment. | All randomized participants from the ITT Population | Posted | Median | 95% Confidence Interval | minutes | From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes) |
|
|
|
| Secondary | Time to First Perceptible Pain Relief | Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. | All randomized participants from the ITT Population. | Posted | Median | 95% Confidence Interval | minutes | From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes) |
|
|
|
| Secondary | Time to Meaningful Pain Relief | Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first. | All randomized participants from the ITT Population. | Posted | Median | 95% Confidence Interval | minutes | From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes) |
|
|
|
| Secondary | Percentage of Participants Using Rescue Medication for Pain | The percentage of participants who needed to take an alternate medication for pain relief during the treatment period. | All randomized participants from the ITT Population. | Posted | Number | percentage of participants | From Time 0 (first dose of study drug) up to 48 hours |
|
|
|
| Secondary | Time to First Use of Rescue Medication for Pain | Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment. | All randomized participants from the ITT Population. | Posted | Median | 95% Confidence Interval | minutes | From Time 0 to time of first use of rescue medication (up to 280 minutes) |
|
|
|
| Secondary | Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours | Total use of rescue medication is defined as the number of times a participant took rescue medication. | All randomized participants from the ITT Population who used rescue medication during the specified time intervals. | Posted | Mean | Standard Deviation | number of uses | Over 24 and 48 hours after Time 0 (first dose of study drug) |
|
|
|
| Secondary | Participant's Global Evaluation of Study Drug | Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported. | All randomized participants from the ITT Population. | Posted | Number | percentage of participants | End of treatment (Day 3) or early termination |
|
|
|
| 0 |
| 79 |
| 38 |
| 79 |
| EG001 | Buprenorphine 0.5 mg TID | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) for two days. | 1 | 81 | 76 | 81 |
| EG002 | Buprenorphine 0.25 mg TID | Participants received buprenorphine 0.25 mg sublingual spray TID for two days. | 0 | 80 | 67 | 80 |
| EG003 | Buprenorphine 0.125 mg TID | Participants received buprenorphine 0.125 mg sublingual spray TID for two days. | 0 | 82 | 57 | 82 |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| D010335 | Pathologic Processes |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
|
| 8 Hours |
|
|
| 24 Hours |
|
|
| 48 Hours |
|
|
|
| 8 Hours |
|
|
| 24 Hours |
|
|
| 48 Hours |
|
|
|
| SPID-8 |
|
|
| SPID-24 |
|
|
|
| TOTPAR-8 |
|
|
| TOTPAR-24 |
|
|
| TOTPAR-48 |
|
|
| 4 Hours - A little relief |
|
| 4 Hours - Some relief |
|
| 4 Hours - A lot of relief |
|
| 4 Hours - Complete relief |
|
| 8 Hours - No relief |
|
| 8 Hours - A little relief |
|
| 8 Hours - Some relief |
|
| 8 Hours - A lot of relief |
|
| 8 Hours - Complete relief |
|
| 24 Hours - No relief |
|
| 24 Hours - A little relief |
|
| 24 Hours - Some relief |
|
| 24 Hours - A lot of relief |
|
| 24 Hours - Complete relief |
|
| 48 Hours - No relief |
|
| 48 Hours - A little relief |
|
| 48 Hours - Some relief |
|
| 48 Hours - A lot of relief |
|
| 48 Hours - Complete relief |
|
| A little relief |
|
| Some relief |
|
| A lot of relief |
|
| Complete relief |
|
| A lot of relief + Complete relief |
|
|
| 0-48 Hours |
|
|
| Fair |
|
| Good |
|
| Very Good |
|
| Excellent |
|