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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 hysterectomy 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 the efficacy and safety of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SABER-Bupivacaine Treatment 1a | Experimental | double-blind |
|
| Placebo SABER-Bupivacaine Treatment 1b | Placebo Comparator | double-blind |
|
| Bupivacaine HCl Treatment 1c | Active Comparator | double-blind |
|
| SABER-Bupivacaine Treatment 2a | Experimental | double-blind |
|
| Placebo SABER-Bupivacaine Treatment 2b | Placebo Comparator | double-blind |
|
| Bupivacaine HCl Treatment 2c | Active Comparator | double-blind |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SABER-Bupivacaine Treatment 1a | Drug | 5.0 ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (PI) | Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. 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 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-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 | Paris | France | ||||
| Nycomed |
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| ID | Title | Description |
|---|---|---|
| FG000 | SABER-Bupivacaine | 5 mL, single dose instilled into surgical incision |
| FG001 | SABER-placebo | 5 mL, single dose instilled into surgical incision |
| 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 | 40 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 | 40 ml |
|
| 0-7 days after surgery |
| Bayreuth |
| Germany |
| Nycomed | Dresden | Germany |
| Nycomed | Békéscsaba | Hungary |
| Nycomed | Budapest | Hungary |
| Nycomed | Debrecen | Hungary |
| Nycomed | Győr | Hungary |
| Nycomed | Nyíregyháza | Hungary |
| Nycomed | Székesfehérvár | Hungary |
| Nycomed | Szolnok | Hungary |
| Nycomed | Tatabánya | Hungary |
| Nycomed | Riga | Latvia |
| Nycomed | Stockholm | Sweden |
| Nycomed | London | United Kingdom |
| FG002 | Bupivacaine HCl | 0.25% 40 mL, single dose infiltrated peri-incisionally |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SABER-Bupivacaine | 5 mL, single dose instilled into surgical incision |
| BG001 | SABER-placebo | 5 mL, single dose instilled into surgical incision |
| BG002 | Bupivacaine HCl | 0.25% 40 mL, single dose infiltrated peri-incisionally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Full Range | kg/m^2 |
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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) | Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. 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 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 | Mean | Standard Deviation | score on a scale | 1 to 72 hours post-surgery |
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| Primary | Supplemental Opioid Use | Cumulative IV morphine-equivalent dose of opioid rescue medication | ITT population (patients with data available) | Posted | Mean | Standard Deviation | mg | 0-3 days after surgery |
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| Secondary | Time to First Opioid Rescue Medication Usage | ITT population (patients with data available) | Posted | Median | Standard Deviation | 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. | ITT population (patients with data available) | 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 into surgical incision | 0 | 60 | 7 | 60 | 48 | 60 |
| EG001 | SABER-placebo | 5 mL, single dose instilled into surgical incision | 0 | 27 | 0 | 27 | 17 | 27 |
| EG002 | Bupivacaine HCl | 0.25% 40 mL, single dose infiltrated peri-incisionally | 0 | 27 | 0 | 27 | 19 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ECG abnormal | Investigations | Non-systematic Assessment |
| ||
| ECG QT prolonged | Investigations | Non-systematic Assessment |
| ||
| Haematoma infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Renal neoplasm | 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 |
|---|---|---|---|---|---|
| Post procedural contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| CRP increased | Investigations | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Blood potassium decreased | Investigations | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Incision site haematoma | Injury, poisoning and procedural complications | 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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0.25% 40 mL, single dose infiltrated peri-incisionally |
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