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| Name | Class |
|---|---|
| Nycomed | INDUSTRY |
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This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.
The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | 5.0 mL SABER-Bupivacaine/Once |
|
| Group 2: SABER-Placebo | Placebo Comparator | 5.0 mL SABER-Placebo/Once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABER-Bupivacaine | Drug | Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose. | Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed. | 0 to 72 hours post-dose |
| Supplemental Opioid Use | Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose | 0 to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number (Frequency) of Participants Reporting Opioid-related Adverse Events | Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention. | 0 to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitri Lissin, MD | Durect | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead | New South Wales | 2145 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22510183 | Derived | Hadj A, Hadj A, Hadj A, Rosenfeldt F, Nicholson D, Moodie J, Turner R, Watts R, Fletcher I, Abrouk N, Lissin D. Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial. ANZ J Surg. 2012 Apr;82(4):251-7. doi: 10.1111/j.1445-2197.2011.05754.x. Epub 2011 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: SABER-Bupivacaine | 5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once |
| FG001 | Group 2: SABER-Placebo | 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: SABER-Bupivacaine | 5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once |
| BG001 | Group 2: SABER-Placebo |
| 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 | Mean Pain Intensity on Movement AUC (Time Normalized Area Under the Curve) During the Period 0 to 72 Hours Post-dose. | Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed. | Posted | Mean | Standard Deviation | score on a scale | 0 to 72 hours 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 | Group 1: SABER-Bupivacaine | 5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Scott | Durect Corporation | 408-777-1417 | deborah.scott@durect.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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| SABER-Placebo | Drug | Injectable Solution; 5.0 mL SABER-Placebo/Once |
|
| Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose). |
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed. |
| 0 to 48 hours post-dose |
| Supplemental Opioid Use | Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose) | 0 to 48 hours post-dose |
| Time-to-first Use of Opioid Supplemental Pain Medication | 0 to 14 days post-dose |
| Severity of Opioid-related Side Effects | 0 to 14 days post-dose |
| Kippa-Ring |
| Queensland |
| 4021 |
| Australia |
| Adelaide | South Australia | 5000 | Australia |
| Toorak Gardens | South Australia | 5065 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Hampton | Victoria | 3188 | Australia |
| Ringwood East | Victoria | 3135 | Australia |
| Christchurch | New Zealand |
| Hamilton | New Zealand |
5.0 mL SABER-Placebo/Once
SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Group 2: SABER-Placebo | 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once |
|
|
|
| Primary | Supplemental Opioid Use | Mean total morphine-equivalent dose during the period 0 to 72 hours post-dose | Posted | Mean | Standard Deviation | mg | 0 to 72 hours post-dose |
|
|
|
|
| Secondary | Number (Frequency) of Participants Reporting Opioid-related Adverse Events | Frequency of subject-reported opioid-related AEs during 0 to 72 hours (0 to 3 days) post-dose and during the trial: constipation, drowsiness, dizziness, nausea, vomiting, respiratory depression, and urinary retention. | Posted | Count of Participants | Participants | 0 to 72 hours post-dose |
|
|
|
| Secondary | Mean Pain Intensity on Movement AUC (Time-normalized AUC) During the Period 0 to 48 Hours Post-dose (0 to 2 Days Post-dose). | Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 48 hours post-dose (0 to 2 days post-dose). Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed. | Posted | Mean | Standard Deviation | score on a scale | 0 to 48 hours post-dose |
|
|
|
| Secondary | Supplemental Opioid Use | Mean total morphine-equivalent dose during the period 0 to 48 hours post-dose (0 to 2 days post-dose) | Posted | Mean | Standard Deviation | mg | 0 to 48 hours post-dose |
|
|
|
| Secondary | Time-to-first Use of Opioid Supplemental Pain Medication | Posted | Median | 95% Confidence Interval | hours | 0 to 14 days post-dose |
|
|
|
| Secondary | Severity of Opioid-related Side Effects | Severity of opioid related side effects were not collected in the opioid related side effects diary. | Posted | 0 to 14 days post-dose |
|
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| 0 |
| 40 |
| 1 |
| 40 |
| 38 |
| 40 |
| EG001 | Group 2: SABER-Placebo | 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 5.0 mL SABER-Placebo/Once | 0 | 20 | 0 | 20 | 19 | 20 |
| Abdominal Pain | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Mouth Ulceration | Gastrointestinal disorders |
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| Paraesthesia Oral | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Oedema Peripheral | General disorders |
|
| Pyrexia | General disorders |
|
| Sensation Of Pressure | General disorders |
|
| Rhinitis | Infections and infestations |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Post Procedural Swelling | Injury, poisoning and procedural complications |
|
| Procedural Pain | Injury, poisoning and procedural complications |
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| Blood Pressure Increased | Investigations |
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| Respiratory Rate Decreased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
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| Dysgeusia | Nervous system disorders |
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| Headache | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
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| Dysuria | Renal and urinary disorders |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Day 0 : Drowsiness |
|
| Day 0 : Nausea |
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| Day 0 : Respiratory Depression |
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| Day 0 : Urinary Retention |
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| Day 0 : Vomiting |
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| Day 1 : Constipation |
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| Day 1 : Dizziness |
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| Day 1 : Drowsiness |
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| Day 1 : Nausea |
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| Day 1 : Respiratory Depression |
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| Day 1 : Urinary Retention |
|
| Day 1 : Vomiting |
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| Day 2 : Constipation |
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| Day 2 : Dizziness |
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| Day 2 : Drowsiness |
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| Day 2 : Nausea |
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| Day 2 : Respiratory Depression |
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| Day 2 : Urinary Retention |
|
| Day 2 : Vomiting |
|
| Day 3 : Constipation |
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| Day 3 : Dizziness |
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| Day 3 : Drowsiness |
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| Day 3 : Nausea |
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| Day 3 : Respiratory Depression |
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| Day 3 : Urinary Retention |
|
| Day 3 : Vomiting |
|