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| Name | Class |
|---|---|
| Nycomed | INDUSTRY |
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The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABER-Bupivacaine Treatment 1a | Experimental | double-blind |
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| Placebo SABER-Bupivacaine Treatment 1b | Placebo Comparator | double-blind |
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| Bupivacaine HCl Treatment 1c | Active Comparator | double-blind |
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| SABER-Bupivacaine Treatment 2a | Experimental | double-blind |
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| Placebo SABER-Bupivacaine Treatment 2b | Placebo Comparator | double-blind |
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| Bupivacaine HCl Treatment 2c | Active Comparator | double-blind |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABER-Bupivacaine Treatment 1a | Drug | 5.0 ml |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (PI) | Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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. | 0-3 days after surgery |
| Supplemental Opioid Use | Cumulative IV morphine-equivalent dose of opioid rescue medication | 0-3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Opioid Rescue Medication Usage | 0-14 days after surgery | |
| Opioid Related Side Effects | Opioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, >6 episodes=4). On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nycomed Clinical Trial Operations | Headquarters | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational Site | Graz | Austria | ||||
| Nycomed Investigational Site |
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Multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled study in adult subjects undergoing elective arthroscopic subacromial decompression.
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| ID | Title | Description |
|---|---|---|
| FG000 | SABER-Bupivacaine 5 mL | 5 mL, single dose instilled subacromially |
| FG001 | SABER-placebo 5 mL | 5 mL, single dose instilled subacromially |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo SABER-Bupivacaine Treatment 1b | Drug | 5.0 ml |
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| Bupivacaine HCl Treatment 1c | Drug | 20.0 ml |
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| SABER-Bupivacaine Treatment 2a | Drug | 7.5 ml |
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| Placebo SABER-Bupivacaine Treatment 2b | Drug | 7.5 ml |
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| Bupivacaine HCl Treatment 2c | Drug | 20.0 ml |
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| 0-7 days after surgery |
| Vienna |
| 1090 |
| Austria |
| Nycomed Investigational Site | Vienna | 1130 | Austria |
| Nycomed Investigational Site | Berlin | Germany |
| Nycomed Investigational Site | Dresden | Germany |
| Nycomed Investigational Site | Marburg | Germany |
| Nycomed Investigational Site | Riga | Latvia |
| Nycomed Investigational Site | Valmiera | Latvia |
| Nycomed Investigational Site | Lodz | Poland |
| Nycomed Investigational Site | Stockholm | Sweden |
| FG002 | Bupivacaine HCl 0.25% 20 mL | 0.25% 20 mL, single dose instilled subacromially |
| FG003 | SABER- Placebo 7.5 mL | 7.5 mL, single dose instilled subacromially. This arm was never pursued. |
| FG004 | SABER-Bupivacaine 7.5 mL | 7.5 mL, single dose instilled subacromially. This arm was never pursued. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SABER-Bupivacaine | 5 mL, single dose instilled subacromially |
| BG001 | SABER-placebo | 5 mL, single dose instilled subacromially |
| BG002 | Bupivacaine HCl | 0.25% 20 mL, single dose instilled subacromially |
| BG003 | 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 | Full Range | years |
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| Sex: Female, Male | Count of Participants | 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 (PI) | Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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. | Posted | Mean | Standard Deviation | score on a scale (time-normalized AUC) | 0-3 days after surgery |
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| Primary | Supplemental Opioid Use | Cumulative IV morphine-equivalent dose of opioid rescue medication | Posted | Median | Inter-Quartile Range | mg | 0-3 days after surgery |
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| Secondary | Time to First Opioid Rescue Medication Usage | Posted | Median | 95% Confidence Interval | hours | 0-14 days after surgery |
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| Secondary | Opioid Related Side Effects | Opioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, >6 episodes=4). On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score. | Posted | Mean | Standard Deviation | score on a scale | 0-7 days after surgery |
|
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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 | 5 mL, single dose instilled subacromially | 0 | 53 | 1 | 53 | 12 | 53 |
| EG001 | SABER-placebo | 5 mL, single dose instilled subacromially | 0 | 25 | 1 | 25 | 6 | 25 |
| EG002 | Bupivacaine HCl | 0.25% 20 mL, single dose instilled subacromially | 0 | 29 | 4 | 29 | 6 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders |
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| Drug intolerance | General disorders |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders |
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| Tongue paralysis | Nervous system disorders |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| ALT increased | Investigations | Non-systematic Assessment |
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| ECG T wave abnormal | Investigations | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Scott | Durect Corporation | 408-777-1417 | deborah.scott@durect.com |
| 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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| Male |
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