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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. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.
The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: SABER-Bupivacaine | Experimental | 2.5 mL SABER-Bupivacaine/Once |
|
| Group 2: SABER-Bupivacaine | Experimental | 5.0 mL SABER-Bupivacaine/Once |
|
| Group 3: SABER-Placebo | Placebo Comparator | 2.5 mL or 5.0 mL SABER-Placebo/Once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABER-Bupivacaine | Drug | Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity on Movement | Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude. | 1 to 72 hours post-dose |
| Proportion (Percent) of Patients Using Supplemental Opioids | 0 to 14 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude. |
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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 |
|---|---|---|---|---|---|---|
| Cairns | Queensland | 4870 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22510183 | Result | 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 | 2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once |
| FG001 | Group 2: SABER-Bupivacaine | 5.0 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once |
| FG002 | Group 3: SABER-Placebo | 2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once (SABER-Placebo 2.5 mL or 5.0 mL, as randomly assigned) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: SABER-Bupivacaine | 2.5 mL SABER-Bupivacaine/Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once |
| BG001 | Group 2: SABER-Bupivacaine |
| 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 | Pain Intensity on Movement | Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude. | ITT population (patients with data available) | Posted | Least Squares Mean | Standard Error | score on a scale | 1 to 72 hours post-dose |
|
Through study completion, approximately 14 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 | Group 1: SABER-Bupivacaine | 2.5 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine(330 mg)/Once |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac 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 |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| SABER-Bupivacaine | Drug | Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once |
|
|
| SABER-Placebo | Drug | Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once |
|
| 1 to 48 hours post-dose |
| Treatment Satisfaction | Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied). | 1 to 5 days post-dose |
| Supplemental Opioid Use | 0 to 14 days post-dose |
| Mean Function Activities (Modified Brief Pain Inventory) | In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference) | 1 to 5 days post-dose |
| Sunnybank |
| Queensland |
| 4109 |
| Australia |
| Port Lincoln | South Australia | 5606 | Australia |
| Ringwood East | Victoria | 3135 | Australia |
| Hamilton | New Zealand |
5.0 mL SABER-Bupivacaine/Once
SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once
| BG002 | Group 3: SABER-Placebo | 2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once |
| BG003 | 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-Bupivacaine | 5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine(660 mg)/Once |
| OG002 | Group 3: SABER-Placebo | 2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once |
|
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| Primary | Proportion (Percent) of Patients Using Supplemental Opioids | ITT population (patients with data available) | Posted | Count of Participants | Participants | 0 to 14 days post-dose |
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| Secondary | Pain Intensity | Pain intensity AUC over the time period of 1 to 48 hours. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude. | ITT population (patients with data available) | Posted | Least Squares Mean | Standard Error | score on a scale | 1 to 48 hours post-dose |
|
|
|
| Secondary | Treatment Satisfaction | Modified Brief Pain Inventory -An overall assessment of treatment satisfaction was made using 6 point verbal rating scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied). | ITT population (patients with data available) | Posted | Count of Participants | Participants | 1 to 5 days post-dose |
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| Secondary | Supplemental Opioid Use | ITT population (patients with data available) | Posted | Mean | Standard Deviation | Total morphine equivalent dose (mg) | 0 to 14 days post-dose |
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| Secondary | Mean Function Activities (Modified Brief Pain Inventory) | In past 24 hours, pain interfered with ability to function or perform activity (0-10 numeric scale, 0=no interference) | ITT population (patients with data available) | Posted | Mean | Standard Deviation | score on a scale | 1 to 5 days post-dose |
|
|
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| 0 |
| 44 |
| 3 |
| 44 |
| 44 |
| 44 |
| EG001 | Group 2: SABER-Bupivacaine | 5.0 mL SABER-Bupivacaine /Once SABER-Bupivacaine: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine (660 mg) /Once | 0 | 47 | 2 | 47 | 44 | 47 |
| EG002 | Group 3: SABER-Placebo | 2.5 mL or 5.0 mL SABER-Placebo/Once SABER-Placebo: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once | 0 | 32 | 1 | 32 | 31 | 32 |
| Postoperative wound complication | Injury, poisoning and procedural complications |
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| Syncope | Nervous system disorders |
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| Syncope vasovagal | Nervous system disorders |
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| Tinnitus | Ear and labyrinth disorders |
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| Constipation | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Application site discoloration | General disorders |
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| Pyrexia | General disorders |
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| Incision site infection | Infections and infestations |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Dizziness | Nervous system disorders |
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| Dysgeusia | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Paraesthesia | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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| Hypotension | Vascular disorders |
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| Incision site oedema | Injury, poisoning and procedural complications |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| Dissatisfied |
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| Slightly Dissatisfied |
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| Slightly Satisfied |
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| Satisfied |
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| Very Satisfied |
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| get out of bed (Day 2) |
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| get out of bed (Day 3) |
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| get out of bed (Day 4) |
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| get out of bed (Day 5) |
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| Ability to walk (Day 1) |
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| Ability to walk (Day 2) |
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| Ability to walk (Day 3) |
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| Ability to walk (Day 4) |
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| Ability to walk (Day 5) |
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| Ability To Interact With Visitors (Day 1) |
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| Ability To Interact With Visitors (Day 2) |
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| Ability To Interact With Visitors (Day 3) |
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| Ability To Interact With Visitors (Day 4) |
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| Ability To Interact With Visitors (Day 5) |
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| Ability To Fall Asleep (Day 1) |
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| Ability To Fall Asleep (Day 2) |
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| Ability To Fall Asleep (Day 3) |
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| Ability To Fall Asleep (Day 4) |
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| Ability To Fall Asleep (Day 5) |
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| Ability To Stay Asleep (Day 1) |
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| Ability To Stay Asleep (Day 2) |
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| Ability To Stay Asleep (Day 3) |
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| Ability To Stay Asleep (Day 4) |
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| Ability To Stay Asleep (Day 5) |
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| Ability To Eat (Day 1) |
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| Ability To Eat (Day 2) |
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| Ability To Eat (Day 3) |
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| Ability To Eat (Day 4) |
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| Ability To Eat (Day 5) |
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| Ability To Deep Breath (Day 1) |
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| Ability To Deep Breath (Day 2) |
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| Ability To Deep Breath (Day 3) |
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| Ability To Deep Breath (Day 4) |
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| Ability To Deep Breath (Day 5) |
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| Ability To Cough (Day 1) |
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| Ability To Cough (Day 2) |
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| Ability To Cough (Day 3) |
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| Ability To Cough (Day 4) |
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| Ability To Cough (Day 5) |
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