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This is a research study of SABER® -Bupivacaine, an experimental medication designed to reduce pain for up to 3 days after surgery. Given once by the surgeon at the end of surgery, SABER® - Bupivacaine delivers a locally-acting pain reliever directly to the surgical wound.
The purpose of this study is to measure how well it works in reducing pain after laparoscopic cholecystectomy (surgery to remove the gall bladder) and to investigate the safety of SABER®-Bupivacaine (its side effects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Placebo Comparator | SABER-Bupivacaine and Saline Placebo |
|
| Part 2 | Active Comparator | SABER-Bupivacaine and Bupivacaine HCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABER-Bupivacaine (Part 1) | Drug | 5 ml once at end of surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity on Movement From 0-48 Hours Post-Treatment | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group. | Assessed from 0 to 48 hours post-dose, summary measure (see description) reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Using the NPRS-11 With Movement | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 17 planned time points from 0 to 72 hours post-treatment. The values reported are mean pain scores for each treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Ellis, MD | Durect | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durect Study Site 04 | Florence | Alabama | 35360 | United States | ||
| Durect Study Site 03 |
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The study was conducted at 22 sites in the US. First subject was randomized on 17 November 2015. Study completion date was on 16 Aug 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | SABER-Bupivacaine (Part 1) | 5 ml once at end of surgery |
| FG001 | Saline Placebo (Part 1) | 5 ml once at end of surgery |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2017 |
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| SABER-Bupivacaine (Part 2) | Drug | 5 ml once at end of surgery |
|
|
| Saline Placebo | Drug | 5 ml once at end of surgery |
|
|
| Bupivacaine HCl | Drug | 0.5%, 15 ml, once at end of surgery |
|
| Assessed from 0 to 72 hours post-dose, summary measure (see description) reported. |
| Total IV Morphine-equivalent Dose of Rescue Opioids | IV morphine-equivalent dose | 0-72 hrs. post dose (after surgery) |
| Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | Score of Integrated Analgesia (SIA) is a composite endpoint that integrates pain assessment scores with opioid use over various collections of timepoints by ranking the pain score and the opioid use separately across treatments. After the scores are computed the means are calculated across time points to provide a single overall treatment effect. The composite SIA score ranges from -200 to 200 with -200 being the best case and 200 the worst case. | 0 to 72 hours |
| Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl | From PACU Discharge to 72 Hours post-treatment |
| Time to First Opioid Rescue Medication Use After Discharge From the PACU | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl | From PACU Discharge to 72 Hours post-treatment |
| Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS) | mPADSS is a tool used to determine eligibility for discharge from the PACU after ambulatory surgery. It includes an assessment of parameters such as vital signs, activity level, nausea/vomiting, pain, and surgical bleeding. For this trial, evaluation of eligibility for PACU discharge by mPADSS has been slightly modified to provide a standardized means of assessing eligibility for PACU discharge across multiple investigative sites and also ensures that nonmedical complications, such as a missing ride home, do not interfere with evaluation of test drug effects. | From admission to discharge from PACU (Approximately 0 to 12 hours) |
| Sheffield |
| Alabama |
| 35660 |
| United States |
| DURECT Study Site 24 | Arcadia | California | 91007 | United States |
| Durect Study Site 15 | Fontana | California | 92335 | United States |
| Durect Study Site 02 | Laguna Hills | California | 92653 | United States |
| Durect Study Site 18 | Laguna Hills | California | 92653 | United States |
| Durect Study Site 22 | Pensacola | Florida | 32503 | United States |
| Durect Study Site 12 | Indianapolis | Indiana | 46202 | United States |
| Durect Study Site 21 | Royal Oak | Michigan | 48073 | United States |
| Durect Study Site 17 | Jackson | Mississippi | 39202 | United States |
| Durect Study Site 16 | Las Vegas | Nevada | 89104 | United States |
| Durect Study Site 20 | Las Vegas | Nevada | 89109 | United States |
| Durect Study Site 05 | Stony Brook | New York | 11794 | United States |
| Durect Study Site 13 | Durham | North Carolina | 27710 | United States |
| Durect Study Site 09 | Cleveland | Ohio | 44106 | United States |
| Durect Study Site 11 | Cleveland | Ohio | 44111 | United States |
| Durect Study Site 07 | Cleveland | Ohio | 44195 | United States |
| Durect Study Site 14 | Philadelphia | Pennsylvania | 19107 | United States |
| Durect Study Site 08 | Houston | Texas | 77004 | United States |
| DURECT Study Site 01 | Houston | Texas | 77043 | United States |
| Durect Study Site 23 | Plano | Texas | 75093 | United States |
| FG002 | SABER-Bupivacaine (Part 2) | 5 ml once at end of surgery |
| FG003 | Bupivacaine HCL (Part 2) | 0.5%, 15 ml, once at end of surgery |
|
| Dosed | ITT subjects who are randomized and dosed. One subject in Part 1 was randomized to receive SABER-Bupivacaine but was treated with Saline Placebo (the safety population includes subjects as randomized). |
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| COMPLETED |
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| NOT COMPLETED |
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All Enrolled Subjects (ITT population)
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| ID | Title | Description |
|---|---|---|
| BG000 | SABER-Bupivacaine (Part 1) | 5 ml once at end of surgery |
| BG001 | Saline Placebo (Part 1) | 5 ml once at end of surgery |
| BG002 | SABER-Bupivacaine (Part 2) | 5 ml once at end of surgery |
| BG003 | Bupivacaine HCL (Part 2) | 0.5%, 15 ml, once at end of surgery |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 From 0-48 Hours Post-Treatment | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 13 planned time points from 0 to 48 hours post-treatment. The values reported are mean pain scores for each treatment group. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 2) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified primary outcome measure that included the SABER-Bupivacaine (Part 1) arm or the Saline Placebo (Part 1) arm. | Posted | Mean | Standard Error | score on a scale | Assessed from 0 to 48 hours post-dose, summary measure (see description) reported. |
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| Secondary | Pain Intensity Using the NPRS-11 With Movement | A derived measure computed based on a patient-reported numerical pain rating scale assessing pain as a whole number from 0 (no pain) to 10 (worst pain imaginable) when the subject sits up from a supine position. This measure was evaluated by electronic diary at 17 planned time points from 0 to 72 hours post-treatment. The values reported are mean pain scores for each treatment group. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Mean | Standard Error | score on a scale | Assessed from 0 to 72 hours post-dose, summary measure (see description) reported. |
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| Secondary | Total IV Morphine-equivalent Dose of Rescue Opioids | IV morphine-equivalent dose | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Mean | Standard Error | IV morphine equivalent (mg) | 0-72 hrs. post dose (after surgery) |
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| Secondary | Composite Endpoint of Silverman's Integrated Analgesic (SIA) Assessment Score | Score of Integrated Analgesia (SIA) is a composite endpoint that integrates pain assessment scores with opioid use over various collections of timepoints by ranking the pain score and the opioid use separately across treatments. After the scores are computed the means are calculated across time points to provide a single overall treatment effect. The composite SIA score ranges from -200 to 200 with -200 being the best case and 200 the worst case. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Mean | Standard Error | score on a scale | 0 to 72 hours |
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| Secondary | Subjects Not Taking Rescue Medication From PACU Discharge to 72 Hours | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Number | participants | From PACU Discharge to 72 Hours post-treatment |
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| Secondary | Time to First Opioid Rescue Medication Use After Discharge From the PACU | Pooled SABER-Bupivacaine parts 1 + 2 vs. Bupivacaine HCl | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Median | 95% Confidence Interval | hours | From PACU Discharge to 72 Hours post-treatment |
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| Secondary | Time to PACU Discharge Eligibility as Assessed by Modified Post-Anesthesia Discharge Scoring System (mPADSS) | mPADSS is a tool used to determine eligibility for discharge from the PACU after ambulatory surgery. It includes an assessment of parameters such as vital signs, activity level, nausea/vomiting, pain, and surgical bleeding. For this trial, evaluation of eligibility for PACU discharge by mPADSS has been slightly modified to provide a standardized means of assessing eligibility for PACU discharge across multiple investigative sites and also ensures that nonmedical complications, such as a missing ride home, do not interfere with evaluation of test drug effects. | mITT Population, results for only the prespecified analysis population {SABER-Bupivacaine (Part 1 and Part 2 combined) and Bupivacaine HCl (Part 2)} are provided, there was no prespecified secondary outcome measure that included the Saline Placebo (Part 1) arm or the SABER-Bupivacaine (Part 1) arm as a standalone treatment group. | Posted | Median | 95% Confidence Interval | hours | From admission to discharge from PACU (Approximately 0 to 12 hours) |
|
Approximately 0-60 days after surgery (duration of time over which each participant was assessed).
Systematic and Non-systematic reported TEAEs of >5% (Safety Population)
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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 | SABER-Bupivacaine (Part 1) | 5 ml once at end of surgery | 0 | 45 | 1 | 45 | 43 | 45 |
| EG001 | Saline Placebo (Part 1) | 5 ml once at end of surgery | 0 | 47 | 0 | 47 | 47 | 47 |
| EG002 | SABER-Bupivacaine (Part 2) | 5 ml once at end of surgery | 0 | 148 | 5 | 148 | 148 | 148 |
| EG003 | Bupivacaine HCL (Part 2) | 0.5%, 15 ml, once at end of surgery | 0 | 148 | 3 | 148 | 146 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
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| Post procedural bile leak | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Constipation (Solicited) | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Dizziness (Solicited) | Nervous system disorders | Systematic Assessment |
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| Dysgeusia (Solicited) | Gastrointestinal disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Headache (Solicited) | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia (Solicited) | Nervous system disorders | Systematic Assessment |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Nausea | Nervous system disorders | Non-systematic Assessment |
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| Nausea (solicited) | Nervous system disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Paraesthesia (Solicited) | Nervous system disorders | Systematic Assessment |
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| Post procedural contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Post procedural discharge | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pruritus (Solicited) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Somnolence (Solicited) | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Vomiting (Solicited) | Gastrointestinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Scott | Durect Corporation | 408-777-1417 | deborah.scott@durect.com |
| Mar 3, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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